Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-01-13 @ 8:30 AM
Study NCT ID:
NCT01907906
Status:
COMPLETED
Last Update Posted:
2015-08-18
First Post:
2013-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Inactivation of Whole Blood With Mirasol
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '(303) 231-4832', 'title': 'Ray Goodrich, PhD', 'organization': 'Terumo BCT Biotechnologies, LLC'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period', 'description': 'Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj).\n\nSAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit', 'eventGroups': [{'id': 'EG000', 'title': 'Mirasol Treated', 'description': 'LR-pRBCs derived from Mirasol-treated WB.', 'otherNumAtRisk': 24, 'otherNumAffected': 11, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Untreated Control', 'description': 'LR-pRBCs derived from untreated WB', 'otherNumAtRisk': 24, 'otherNumAffected': 11, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vessel puncture site bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Infusion site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Haematocrit decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Sinus headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Skin discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Peripheral coldness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Red Blood Cell (RBC) 24-Hour Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirasol Treated', 'description': 'LR-pRBCs derived from Mirasol-treated WB'}, {'id': 'OG001', 'title': 'Untreated Control', 'description': 'LR-pRBCs derived from untreated WB'}], 'classes': [{'categories': [{'measurements': [{'value': '82.51', 'spread': '3.914', 'groupId': 'OG000'}, {'value': '91.70', 'spread': '6.812', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'To evaluate, as per FDA criteria, the 24-hour post transfusion RBC recovery in healthy adult subjects of leuko-reduced packed red blood cells (LR-pRBC) that have been derived from Mirasol-treated fresh WB units and stored at 1 to 6°C for 21 days.\n\n24-hour RBC Recovery is a measure of the % of RBCs that are still functioning 24 hours after they have been reinfused back into the donor following storage over 21 days.', 'unitOfMeasure': '% 24-hour RBC Recovery', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who signed an IC form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected during the first 22 min, 30 sec post-infusion in each treatment period.'}, {'type': 'SECONDARY', 'title': 'Red Blood Cell (RBC) Survival by Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirasol Treated', 'description': 'LR-pRBCs derived from Mirasol-treated WB'}, {'id': 'OG001', 'title': 'Untreated Control', 'description': 'LR-pRBCs derived from untreated WB'}], 'classes': [{'title': 'Linear RBC Survival', 'categories': [{'measurements': [{'value': '60.49', 'spread': '5.574', 'groupId': 'OG000'}, {'value': '81.57', 'spread': '15.474', 'groupId': 'OG001'}]}]}, {'title': 'Linear T50', 'categories': [{'measurements': [{'value': '22.58', 'spread': '4.328', 'groupId': 'OG000'}, {'value': '35.83', 'spread': '7.863', 'groupId': 'OG001'}]}]}, {'title': 'Exponential RBC Survival', 'categories': [{'measurements': [{'value': '46.71', 'spread': '5.630', 'groupId': 'OG000'}, {'value': '67.81', 'spread': '15.492', 'groupId': 'OG001'}]}]}, {'title': 'Exponential T50', 'categories': [{'measurements': [{'value': '22.63', 'spread': '5.286', 'groupId': 'OG000'}, {'value': '39.91', 'spread': '10.485', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Assessment of linear \\& exponential RBC survival and half-life (T50) over 28 days for RBCs derived from Mirasol-treated WB versus RBCs derived from untreated WB.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who signed informed consent,were eligible, had no intercurrent illness or notable signs/symptoms in 24 hrs prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had ≥ 4 blood samples collected within the first 22 min 30 sec post-infusion in each treatment period.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve (AUC) of Red Blood Cell (RBC) Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirasol Treated', 'description': 'LR-pRBCs derived from Mirasol-treated WB'}, {'id': 'OG001', 'title': 'Untreated Control', 'description': 'LR-pRBCs derived from untreated WB'}], 'classes': [{'categories': [{'measurements': [{'value': '1715.2', 'spread': '173.13', 'groupId': 'OG000'}, {'value': '2055.2', 'spread': '158.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Assessment of AUC of RBC survival over 28 days for RBCs derived from Mirasol-treated Whole Blood (WB) versus RBCs derived from untreated WB.', 'unitOfMeasure': 'Days * Percent Recovery', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.'}, {'type': 'SECONDARY', 'title': "Spearman's Correlation Coefficients: 24-Hour Red Blood Cell (RBC) Recovery (%) With Hemolysis (%)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirasol Treated', 'description': 'LR-pRBCs derived from Mirasol-treated WB'}, {'id': 'OG001', 'title': 'Untreated Control', 'description': 'LR-pRBCs derived from untreated WB'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1779', 'groupId': 'OG000'}, {'value': '0.4286', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 hours', 'description': "Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with Hemolysis (%) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB", 'unitOfMeasure': "Spearman's Correlation Coefficient", 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.'}, {'type': 'SECONDARY', 'title': "Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) With Adenosine Triphosphate (ATP) (µmol/g Hgb)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirasol Treated', 'description': 'LR-pRBCs derived from Mirasol-treated WB'}, {'id': 'OG001', 'title': 'Untreated Control', 'description': 'LR-pRBCs derived from untreated WB'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6107', 'groupId': 'OG000'}, {'value': '0.4116', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 hours', 'description': "Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with ATP (µmol/g Hgb) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB", 'unitOfMeasure': "Spearman's Correlation Coefficient", 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.'}, {'type': 'SECONDARY', 'title': "Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) pCO2 (mmHg at 37° C)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirasol Treated', 'description': 'LR-pRBCs derived from Mirasol-treated WB'}, {'id': 'OG001', 'title': 'Untreated Control', 'description': 'LR-pRBCs derived from untreated WB'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0383', 'groupId': 'OG000'}, {'value': '0.0475', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 hours', 'description': "Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with pCO2 (mmHg at 37° C) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB", 'unitOfMeasure': "Spearman's Correlation Coefficient", 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.'}, {'type': 'SECONDARY', 'title': "Spearman's Correlation Coefficients: Linear T50 (Days) With Hemolysis (%)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirasol Treated', 'description': 'LR-pRBCs derived from Mirasol-treated WB'}, {'id': 'OG001', 'title': 'Untreated Control', 'description': 'LR-pRBCs derived from untreated WB'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0592', 'groupId': 'OG000'}, {'value': '0.0564', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'description': "Spearman's Correlation Coefficients comparing Linear T50 (Days) with each of Hemolysis (%) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB", 'unitOfMeasure': "Spearman's Correlation Coefficient", 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.'}, {'type': 'SECONDARY', 'title': "Spearman's Correlation Coefficients: Linear T50 (Days) With Adenosine Triphosphate (ATP) (µmol/g Hgb)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirasol Treated', 'description': 'LR-pRBCs derived from Mirasol-treated WB'}, {'id': 'OG001', 'title': 'Untreated Control', 'description': 'LR-pRBCs derived from untreated WB'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2487', 'groupId': 'OG000'}, {'value': '0.0261', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'description': "Spearman's Correlation Coefficients comparing Linear T50 (Days) with ATP (µmol/g Hgb) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB", 'unitOfMeasure': "Spearman's Correlation Coefficient", 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.'}, {'type': 'SECONDARY', 'title': "Spearman's Correlation Coefficients: Linear T50 (Days) With pCO2 (mmHg at 37° C)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirasol Treated', 'description': 'LR-pRBCs derived from Mirasol-treated WB'}, {'id': 'OG001', 'title': 'Untreated Control', 'description': 'LR-pRBCs derived from untreated WB'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0691', 'groupId': 'OG000'}, {'value': '-0.1065', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'description': "Spearman's Correlation Coefficients comparing Linear T50 (Days) with pCO2 (mmHg at 37° C) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB", 'unitOfMeasure': "Spearman's Correlation Coefficient", 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.'}, {'type': 'SECONDARY', 'title': 'Neoantigenicity - Day 21 Direct Antigen Test (DAT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirasol Treated', 'description': 'Leuko-Reduced packed Red Blood Cells (LR-pRBCs) derived from Mirasol-treated WB'}, {'id': 'OG001', 'title': 'Untreated Control', 'description': 'Leuko-Reduced packed Red Blood Cells (LR-pRBCs) derived from untreated WB'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 21', 'description': 'DAT testing of Red Blood Cells (RBCs) via Anti-immunoglobulin G (Anti-IgG) and Anti Complement Component 3 (Anti-C3) as derived from Mirasol-treated whole blood (WB) versus untreated WB conducted on Day 21 of both Treatment Periods 1 and 2. Number of positive results (indicating a new antigen formation) were recorded.', 'unitOfMeasure': 'Positive results', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who signed an IC Form (were enrolled), and had samples available for the requested test on Day 21 of both Treatment Periods 1 and 2'}, {'type': 'SECONDARY', 'title': 'Neoantigenicity - Day 21 Indirect Antigen Test (IAT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirasol Treated', 'description': 'LR-pRBCs derived from Mirasol-treated WB'}, {'id': 'OG001', 'title': 'Untreated Control', 'description': 'LR-pRBCs derived from untreated WB'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 21 of Treatment Periods 1 and 2', 'description': 'Day 21 IAT testing of RBCs via LISS-15, Anti-IgG and C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating antibody formation to a new antigen) were recorded.', 'unitOfMeasure': 'Positive results', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who signed an IC Form (were enrolled), and had samples available for the requested test on Day 21 of both Treatment Periods 1 and 2'}, {'type': 'SECONDARY', 'title': 'Neoantigenicity - Day 42 Direct Antigen Test (DAT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirasol Treated', 'description': 'LR-pRBCs derived from Mirasol-treated WB'}, {'id': 'OG001', 'title': 'Untreated Control', 'description': 'LR-pRBCs derived from untreated WB'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 42 of Treatment Periods 1 and 2', 'description': 'DAT testing of RBCs via Anti-IgG and Anti-C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating a new antigen formation) were recorded.', 'unitOfMeasure': 'Positive results', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who signed an IC Form (were enrolled), and had samples available for the requested test'}, {'type': 'SECONDARY', 'title': 'Neoantigenicity - Day 42 Indirect Antigen Test (IAT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirasol Treated', 'description': 'LR-pRBCs derived from Mirasol-treated WB'}, {'id': 'OG001', 'title': 'Untreated Control', 'description': 'LR-pRBCs derived from untreated WB'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 42 of Treatment Periods 1 and 2', 'description': 'IAT testing of RBCs via low ionic strength solution (LISS-15), Anti-IgG and C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating antibody formation to a new antigen) were recorded.', 'unitOfMeasure': 'Positive results', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who signed an IC Form (were enrolled), and had samples available for the requested test on Day 42 of both Treatment Periods 1 and 2.'}, {'type': 'SECONDARY', 'title': 'In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirasol Treated', 'description': 'LR-pRBCs derived from Mirasol-treated WB'}, {'id': 'OG001', 'title': 'Untreated Control', 'description': 'LR-pRBCs derived from untreated WB'}], 'classes': [{'categories': [{'measurements': [{'value': '59.2', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '61.0', 'spread': '3.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 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Period 1 (49 days): Donation of WB, UNTREATED on Day 0, LR-pRBCs manufactured \\& stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured \\& stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) Study Exit on Treatment Period 2, Day 49'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1: Mirasol-treated WB Then Untreated WB', 'description': 'Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured \\& stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB, UNTREATED on Day 0, LR-pRBCs manufactured \\& stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) Study Exit on Treatment Period 2, Day 49'}, {'id': 'BG001', 'title': 'Arm 2: Untreated WB Then Mirasol-treated WB', 'description': 'Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB UNTREATED on Day 0, LR-pRBCs manufactured \\& stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured \\& stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Adults ≥ 18 yrs; eligible WB donors with normal health status and vital signs by AABB criteria; negative infectious disease and direct/indirect antiglobulin test (DAT/IAAT), and did not meet any exclusion criteria.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-28', 'studyFirstSubmitDate': '2013-06-20', 'resultsFirstSubmitDate': '2015-05-22', 'studyFirstSubmitQcDate': '2013-07-22', 'lastUpdatePostDateStruct': {'date': '2015-08-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-24', 'studyFirstPostDateStruct': {'date': '2013-07-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Red Blood Cell (RBC) 24-Hour Recovery', 'timeFrame': '24 hours', 'description': 'To evaluate, as per FDA criteria, the 24-hour post transfusion RBC recovery in healthy adult subjects of leuko-reduced packed red blood cells (LR-pRBC) that have been derived from Mirasol-treated fresh WB units and stored at 1 to 6°C for 21 days.\n\n24-hour RBC Recovery is a measure of the % of RBCs that are still functioning 24 hours after they have been reinfused back into the donor following storage over 21 days.'}], 'secondaryOutcomes': [{'measure': 'Red Blood Cell (RBC) Survival by Product', 'timeFrame': '28 days', 'description': 'Assessment of linear \\& exponential RBC survival and half-life (T50) over 28 days for RBCs derived from Mirasol-treated WB versus RBCs derived from untreated WB.'}, {'measure': 'Area Under the Curve (AUC) of Red Blood Cell (RBC) Survival', 'timeFrame': '28 days', 'description': 'Assessment of AUC of RBC survival over 28 days for RBCs derived from Mirasol-treated Whole Blood (WB) versus RBCs derived from untreated WB.'}, {'measure': "Spearman's Correlation Coefficients: 24-Hour Red Blood Cell (RBC) Recovery (%) With Hemolysis (%)", 'timeFrame': '24 hours', 'description': "Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with Hemolysis (%) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB"}, {'measure': "Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) With Adenosine Triphosphate (ATP) (µmol/g Hgb)", 'timeFrame': '24 hours', 'description': "Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with ATP (µmol/g Hgb) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB"}, {'measure': "Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) pCO2 (mmHg at 37° C)", 'timeFrame': '24 hours', 'description': "Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with pCO2 (mmHg at 37° C) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB"}, {'measure': "Spearman's Correlation Coefficients: Linear T50 (Days) With Hemolysis (%)", 'timeFrame': '28 days', 'description': "Spearman's Correlation Coefficients comparing Linear T50 (Days) with each of Hemolysis (%) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB"}, {'measure': "Spearman's Correlation Coefficients: Linear T50 (Days) With Adenosine Triphosphate (ATP) (µmol/g Hgb)", 'timeFrame': '28 days', 'description': "Spearman's Correlation Coefficients comparing Linear T50 (Days) with ATP (µmol/g Hgb) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB"}, {'measure': "Spearman's Correlation Coefficients: Linear T50 (Days) With pCO2 (mmHg at 37° C)", 'timeFrame': '28 days', 'description': "Spearman's Correlation Coefficients comparing Linear T50 (Days) with pCO2 (mmHg at 37° C) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB"}, {'measure': 'Neoantigenicity - Day 21 Direct Antigen Test (DAT)', 'timeFrame': 'Day 21', 'description': 'DAT testing of Red Blood Cells (RBCs) via Anti-immunoglobulin G (Anti-IgG) and Anti Complement Component 3 (Anti-C3) as derived from Mirasol-treated whole blood (WB) versus untreated WB conducted on Day 21 of both Treatment Periods 1 and 2. Number of positive results (indicating a new antigen formation) were recorded.'}, {'measure': 'Neoantigenicity - Day 21 Indirect Antigen Test (IAT)', 'timeFrame': 'Day 21 of Treatment Periods 1 and 2', 'description': 'Day 21 IAT testing of RBCs via LISS-15, Anti-IgG and C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating antibody formation to a new antigen) were recorded.'}, {'measure': 'Neoantigenicity - Day 42 Direct Antigen Test (DAT)', 'timeFrame': 'Day 42 of Treatment Periods 1 and 2', 'description': 'DAT testing of RBCs via Anti-IgG and Anti-C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating a new antigen formation) were recorded.'}, {'measure': 'Neoantigenicity - Day 42 Indirect Antigen Test (IAT)', 'timeFrame': 'Day 42 of Treatment Periods 1 and 2', 'description': 'IAT testing of RBCs via low ionic strength solution (LISS-15), Anti-IgG and C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating antibody formation to a new antigen) were recorded.'}, {'measure': 'In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%)', 'timeFrame': 'Day 0'}, {'measure': 'In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%)', 'timeFrame': 'Day 21'}, {'measure': 'In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP', 'timeFrame': 'Day 0'}, {'measure': 'In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP', 'timeFrame': 'Day 21'}, {'measure': 'In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count', 'timeFrame': 'Day 0'}, {'measure': 'In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count', 'timeFrame': 'Day 21'}, {'measure': 'In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin', 'timeFrame': 'Day 0'}, {'measure': 'In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin', 'timeFrame': 'Day 21'}, {'measure': 'In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C)', 'timeFrame': 'Day 0'}, {'measure': 'In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C)', 'timeFrame': 'Day 21'}, {'measure': 'In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C)', 'timeFrame': 'Day 0'}, {'measure': 'In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C)', 'timeFrame': 'Day 21'}, {'measure': 'In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium', 'timeFrame': 'Day 0'}, {'measure': 'In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium', 'timeFrame': 'Day 21'}, {'measure': 'In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose', 'timeFrame': 'Day 0'}, {'measure': 'In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose', 'timeFrame': 'Day 21'}, {'measure': 'In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate', 'timeFrame': 'Day 0'}, {'measure': 'In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate', 'timeFrame': 'Day 21'}, {'measure': 'In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb', 'timeFrame': 'Day 0'}, {'measure': 'In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb', 'timeFrame': 'Day 21'}, {'measure': 'In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG)', 'timeFrame': 'Day 0'}, {'measure': 'In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG)', 'timeFrame': 'Day 21'}, {'measure': 'In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%)', 'timeFrame': 'Day 0'}, {'measure': 'In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%)', 'timeFrame': 'Day 21'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pathogen reduction technology'], 'conditions': ['Focus of Study: Radiolabel Recovery and Survival of RBCs']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate radiolabeled recovery and survival of autologous red blood cells (RBC), derived from Mirasol-treated fresh whole blood (WB), stored as leukoreduced packed RBC (LR-pRBC), and re-infused in healthy adult subjects', 'detailedDescription': 'This is a feasibility level study conducted to assess the recovery and survival of autologous, radiolabeled leukoreduced packed red blood cells (LR-pRBC) derived from fresh whole blood (WB) units that have been treated with the Mirasol System for Whole Blood (Mirasol System) and stored for 21 days at 1-6°C.1'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Eligible whole blood donor\n* Age ≥ 18 years, of either sex\n* Able to commit to the study follow-up schedule\n* Subjects must have adequate bilateral antecubital venous access for WB collection and follow-up blood draws\n* Negative screening test panel for infectious diseases\n* Subjects of child-bearing potential (female or male) must agree to use effective contraceptive during the course of the study per site guidelines\n* Subjects must agree to report adverse events (AEs) during the required reporting period\n* Negative direct antiglobulin test (DAT) with subject's RBC\n* Negative indirect antiglobulin test (IAT) with subject's serum\n\nInclusion for radiolabeled reinfusion of LR-pRBC on Day 21 (evaluated the day of, prior to, reinfusion):\n\n* Maintenance of healthy status\n* Negative direct antiglobulin test (DAT) with subject's RBC (fresh)\n* Negative indirect antiglobulin test (IAT) with subject's serum (fresh) versus autologous stored LR-pRBC\n* Negative serum or urine pregnancy test in females\n\nExclusion Criteria:\n\n* Any serious medical illness and/or therapy, including: abnormal bleeding episodes, clotting or bleeding disorder, evidence of anemia, myocardial infarction, uncontrolled hypertension, heart disease, surgery with bleeding complications, epilepsy or any major surgery (with general or spinal anesthesia) within the last 6 months\n* Pregnant or nursing females; For women of childbearing potential, negative serum or urine pregnancy tests at the time of WB donation and before the reinfusion are required\n* Unable to give informed consent\n* Participation currently, or within the last 12 months, in another investigational trial that would potentially interfere with the analysis of this investigation (e.g., pharmaceutical)\n* Have received an accumulated radiation dose that would exclude them from the study according to the local radiation safety limits established by each institution\n* Inability to comply with the protocol in the opinion of the investigator"}, 'identificationModule': {'nctId': 'NCT01907906', 'acronym': 'IMPROVEII', 'briefTitle': 'Inactivation of Whole Blood With Mirasol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Terumo BCTbio'}, 'officialTitle': 'Inactivation of Whole Blood With Mirasol : Performance in Red Blood Cells in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'CTS-0080'}, 'secondaryIdInfos': [{'id': 'ERMS#12308001', 'type': 'OTHER_GRANT', 'domain': 'Department of Defense'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Mirasol-treated WB then untreated WB', 'description': 'Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured \\& stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB, UNTREATED on Day 0, LR-pRBCs manufactured \\& stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) Study Exit on Treatment Period 2, Day 49', 'interventionNames': ['Device: Mirasol System for Whole Blood']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: Untreated WB then Mirasol-treated WB', 'description': 'Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB, UNTREATED on Day 0, LR-pRBCs manufactured \\& stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured \\& stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) Study Exit on Treatment Period 2, Day 49', 'interventionNames': ['Device: Mirasol System for Whole Blood']}], 'interventions': [{'name': 'Mirasol System for Whole Blood', 'type': 'DEVICE', 'otherNames': ['Pathogen Reduction Technology'], 'description': 'LR-pRBC units derived from WB will be treated with the Mirasol System. Treatment with the Mirasol System requires riboflavin to be mixed into the whole blood unit, which is then exposed to ultra violet (UV) light for a period of time; approximately an hour.', 'armGroupLabels': ['Arm 1: Mirasol-treated WB then untreated WB', 'Arm 2: Untreated WB then Mirasol-treated WB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Hoxworth Blood Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Puget Sound Blood Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Raymond P Goodrich, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'TerumoBCT Biotechnologies'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Terumo BCTbio', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'U.S. Army Medical Research and Development Command', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}