Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2026-01-28 @ 2:35 PM
Study NCT ID:
NCT02878850
Status:
COMPLETED
Last Update Posted:
2025-11-24
First Post:
2016-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized Trial of Early Hemodynamic Management of Patients Following Acute Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
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The UEMS score ranges from 0 to 50, with 50 indicating no deficits.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ABP: 46 patients allocated to intervention, 8 died, 3 unable to complete physical exam, 16 lost to follow up CBP: 46 patients allocated to intervention, 7 died, 9 unable to complete physical exam, 11 lost to follow up'}, {'type': 'SECONDARY', 'title': 'Spinal Cord Independence Measure III Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Augmented Blood Pressure', 'description': 'Subjects will have their blood pressure kept in a higher range.'}, {'id': 'OG001', 'title': 'Conventional Blood Pressure', 'description': 'Subjects will have their blood pressure kept in a normal range.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.48', 'spread': '19.43', 'groupId': 'OG000'}, {'value': '28.11', 'spread': '20.82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.92', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.63', 'ciLowerLimit': '-12.48', 'ciUpperLimit': '11.21', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months after spinal cord injury', 'description': 'Spinal Cord Independence Measure III (SCIM III). The total SCIM III Score ranges from 0 to 100 points, with 0 indicating complete dependence and 100 indicating complete independence.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Scores on the International Spinal Cord Injury Basic Pain Data Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Augmented Blood Pressure', 'description': 'Subjects will have their blood pressure kept in a higher range.'}, {'id': 'OG001', 'title': 'Conventional Blood Pressure', 'description': 'Subjects will have their blood pressure kept in a normal range.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.21', 'spread': '3.17', 'groupId': 'OG000'}, {'value': '4.86', 'spread': '3.66', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.75', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.35', 'ciLowerLimit': '-1.83', 'ciUpperLimit': '2.53', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months after spinal cord injury', 'description': 'Pain Interference with daily activity on the International Spinal Cord Injury Basic Pain Data Set. 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Satisfaction with life as a whole; 2. Satisfaction with physical health; 3. Satisfaction with psychological health. Each domain scores from 0 to 10, and the total score range (sum of the 3 domains) ranges from 0 to 30. Higher scores indicate better perceived quality of life.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Incidence of Respiratory Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Augmented Blood Pressure', 'description': 'Subjects will have their blood pressure kept in a higher range.'}, {'id': 'OG001', 'title': 'Conventional Blood Pressure', 'description': 'Subjects will have their blood pressure kept in a normal range.'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciPctValue': '95', 'paramValue': '2.00', 'ciLowerLimit': '1.36', 'ciUpperLimit': '2.94', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days after randomization or ICU discharge, whichever came first, assessed up to 7 days', 'description': 'Incidence of respiratory complications', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cardiovascular Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Augmented Blood Pressure', 'description': 'Subjects will have their blood pressure kept in a higher range.'}, {'id': 'OG001', 'title': 'Conventional Blood Pressure', 'description': 'Subjects will have their blood pressure kept in a normal range.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.87', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.44', 'ciUpperLimit': '3.65', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months after spinal cord injury', 'description': 'Hypotension, hypertension, autonomic dysreflexia, edema, pulmonary embolism, deep venous thrombosis, other cardiovascular condition.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Sequential Multiple Organ Assessment (SOFA) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Augmented Blood Pressure', 'description': 'Subjects will have their blood pressure kept in a higher range.'}, {'id': 'OG001', 'title': 'Conventional Blood Pressure', 'description': 'Subjects will have their blood pressure kept in a normal range.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.40', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '1.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '1.32', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '7 days after randomization', 'description': 'Modified Sequential Multiple Organ Assessment (SOFA) score on Day 7 after randomization. The modified SOFA score does not include the points contributed by the Cardiovascular system. The modified SOFA score ranges from 0 to 20, with higher scores indicating greater organ dysfunction and higher mortality risk.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in American Spinal Injury (ASIA) Lower Extremities Motor Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Augmented Blood Pressure', 'description': 'Subjects will have their blood pressure kept in a higher range.'}, {'id': 'OG001', 'title': 'Conventional Blood Pressure', 'description': 'Subjects will have their blood pressure kept in a normal range.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.79', 'spread': '16.66', 'groupId': 'OG000'}, {'value': '16.16', 'spread': '18.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.35', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.73', 'ciLowerLimit': '-16.84', 'ciUpperLimit': '6.10', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months after spinal cord injury', 'description': 'Change from baseline in ASIA Lower Extremities Motor Score (LEMS), comparing patients maintained at a MAP target between 65 and 70 mm Hg, and patients maintained at a MAP target between 85 and 90 mm Hg for a duration of seven days or until ICU discharge. The LEMS score ranges from 0 to 50, with 50 indicating no deficits.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ABP: 46 patients allocated to intervention, 8 died, 3 unable to complete physical exam, 16 lost to follow up CBP: 46 patients allocated to intervention, 7 died, 9 unable to complete physical exam, 11 lost to follow up'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in American Spinal Injury Association (ASIA) Sensory Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Augmented Blood Pressure', 'description': 'Subjects will have their blood pressure kept in a higher range.'}, {'id': 'OG001', 'title': 'Conventional Blood Pressure', 'description': 'Subjects will have their blood pressure kept in a normal range.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.26', 'spread': '41.32', 'groupId': 'OG000'}, {'value': '41.63', 'spread': '58.97', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-35.37', 'ciLowerLimit': '-68.87', 'ciUpperLimit': '-1.87', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months after spinal cord injury', 'description': 'Change from baseline in ASIA Sensory Score, comparing patients maintained at a MAP target between 65 and 70 mm Hg, and patients maintained at a MAP target between 85 and 90 mm Hg for a duration of seven days or until ICU discharge. The total Sensory Score adds light touch points (max 112) and pin prick points (max 112). The total score ranges from 0 to 224, with higher scores indicating better neurological outcomes.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ABP: 46 patients allocated to intervention, 8 died, 3 unable to complete physical exam, 16 lost to follow up CBP: 46 patients allocated to intervention, 7 died, 9 unable to complete physical exam, 11 lost to follow up'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Augmented Blood Pressure', 'description': 'Subjects will have their blood pressure kept in a higher range.'}, {'id': 'FG001', 'title': 'Conventional Blood Pressure', 'description': 'Subjects will have their blood pressure kept in a normal range.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Augmented Blood Pressure', 'description': 'Subjects will have their blood pressure kept in a higher range.'}, {'id': 'BG001', 'title': 'Conventional Blood Pressure', 'description': 'Subjects will have their blood pressure kept in a normal range.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '53.6', 'spread': '17.8', 'groupId': 'BG000'}, {'value': '54.0', 'spread': '17.9', 'groupId': 'BG001'}, {'value': '53.8', 'spread': '17.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline American Spinal Injury Association (ASIA) Score', 'classes': [{'title': 'Upper Extremities Motor Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17.1', 'spread': '13.4', 'groupId': 'BG000'}, {'value': '23.0', 'spread': '17.8', 'groupId': 'BG001'}, {'value': '19.2', 'spread': '15.9', 'groupId': 'BG002'}]}]}, {'title': 'Lower Extremities Motor Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.9', 'spread': '13.6', 'groupId': 'BG000'}, {'value': '6.1', 'spread': '12.2', 'groupId': 'BG001'}, {'value': '6.5', 'spread': '12.8', 'groupId': 'BG002'}]}]}, {'title': 'Total Sensory Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '87.8', 'spread': '54.4', 'groupId': 'BG000'}, {'value': '77.3', 'spread': '44.2', 'groupId': 'BG001'}, {'value': '82.7', 'spread': '49.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The ASIA Score has a motor and a sensory component. The maximum Upper Extremities Motor Score (UEMS) is 50, the maximum Lower Extremities Motor Score (LEMS) is 50, the maximum Total Sensory Score (sum of pin prick \\[max 112\\] and light touch \\[max 112\\]) is 224. The minimum score is 0. Higher scores indicate better neurological outcome.', 'unitOfMeasure': 'Score', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'A complete neurological exam could not be obtained in 3 patients'}], 'populationDescription': '1 participant in the ABP and 1 participant in the CBP group were excluded due to inadequate consent documentation'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-08', 'size': 454044, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-01T18:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2023-07-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-10', 'studyFirstSubmitDate': '2016-08-03', 'resultsFirstSubmitDate': '2025-08-04', 'studyFirstSubmitQcDate': '2016-08-20', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-10', 'studyFirstPostDateStruct': {'date': '2016-08-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-07-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of Respiratory Complications', 'timeFrame': '7 days after randomization or ICU discharge, whichever came first, assessed up to 7 days', 'description': 'Incidence of respiratory complications'}, {'measure': 'Cardiovascular Function', 'timeFrame': '6 months after spinal cord injury', 'description': 'Hypotension, hypertension, autonomic dysreflexia, edema, pulmonary embolism, deep venous thrombosis, other cardiovascular condition.'}, {'measure': 'Sequential Multiple Organ Assessment (SOFA) Score', 'timeFrame': '7 days after randomization', 'description': 'Modified Sequential Multiple Organ Assessment (SOFA) score on Day 7 after randomization. The modified SOFA score does not include the points contributed by the Cardiovascular system. The modified SOFA score ranges from 0 to 20, with higher scores indicating greater organ dysfunction and higher mortality risk.'}], 'primaryOutcomes': [{'measure': 'Change From Baseline in American Spinal Injury (ASIA) Upper Extremities Motor Score', 'timeFrame': '6 months after spinal cord injury', 'description': 'Change from baseline in ASIA Upper Extremities Motor Score (UEMS), comparing patients maintained at a MAP target between 65 and 70 mm Hg, and patients maintained at a MAP target between 85 and 90 mm Hg for a duration of seven days or until ICU discharge. The UEMS score ranges from 0 to 50, with 50 indicating no deficits.'}, {'measure': 'Change From Baseline in American Spinal Injury (ASIA) Lower Extremities Motor Score', 'timeFrame': '6 months after spinal cord injury', 'description': 'Change from baseline in ASIA Lower Extremities Motor Score (LEMS), comparing patients maintained at a MAP target between 65 and 70 mm Hg, and patients maintained at a MAP target between 85 and 90 mm Hg for a duration of seven days or until ICU discharge. The LEMS score ranges from 0 to 50, with 50 indicating no deficits.'}, {'measure': 'Change From Baseline in American Spinal Injury Association (ASIA) Sensory Score', 'timeFrame': '6 months after spinal cord injury', 'description': 'Change from baseline in ASIA Sensory Score, comparing patients maintained at a MAP target between 65 and 70 mm Hg, and patients maintained at a MAP target between 85 and 90 mm Hg for a duration of seven days or until ICU discharge. The total Sensory Score adds light touch points (max 112) and pin prick points (max 112). The total score ranges from 0 to 224, with higher scores indicating better neurological outcomes.'}], 'secondaryOutcomes': [{'measure': 'Spinal Cord Independence Measure III Score', 'timeFrame': '6 months after spinal cord injury', 'description': 'Spinal Cord Independence Measure III (SCIM III). The total SCIM III Score ranges from 0 to 100 points, with 0 indicating complete dependence and 100 indicating complete independence.'}, {'measure': 'Pain Scores on the International Spinal Cord Injury Basic Pain Data Set', 'timeFrame': '6 months after spinal cord injury', 'description': 'Pain Interference with daily activity on the International Spinal Cord Injury Basic Pain Data Set. Pain Interference Score ranges from 0 to 10, with higher scores indicating higher pain levels.'}, {'measure': 'International Spinal Cord Injury Quality of Life (ISCIQoL) Basic Data Set', 'timeFrame': '6 months after spinal cord injury', 'description': 'The ISCIQoL Basic Data Set is a 3-item self-report tool of quality of life across three domains: 1. Satisfaction with life as a whole; 2. Satisfaction with physical health; 3. Satisfaction with psychological health. Each domain scores from 0 to 10, and the total score range (sum of the 3 domains) ranges from 0 to 30. Higher scores indicate better perceived quality of life.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Cord Injury']}, 'referencesModule': {'references': [{'pmid': '40965887', 'type': 'DERIVED', 'citation': 'Sajdeya R, Yanez ND, Kampp M, Goodman MD, Zonies D, Togioka B, Nunn A, Winfield RD, Martin ND, Kohli A, Huynh TT, Okonkwo DO, Poblete RA, Gilmore EJ, Chesnut RM, Bunnell AE, Ohnuma T, Hashemaghaie M, Treggiari MM. Early Blood Pressure Targets in Acute Spinal Cord Injury: A Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2525364. doi: 10.1001/jamanetworkopen.2025.25364.'}, {'pmid': '33003016', 'type': 'DERIVED', 'citation': 'Weinberg JA, Farber SH, Kalamchi LD, Brigeman ST, Bohl MA, Varda BM, Sioda NA, Radosevich JJ, Chapple KM, Snyder LA. Mean arterial pressure maintenance following spinal cord injury: Does meeting the target matter? J Trauma Acute Care Surg. 2021 Jan 1;90(1):97-106. doi: 10.1097/TA.0000000000002953.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn more about how participants heal from acute spinal cord injury.', 'detailedDescription': 'In this study, the investigators will learn about the effect of targeted blood pressure management (TPM) on participants healing from acute spinal cord injury.\n\nThe investigators want to learn:\n\nThe effect of two types of TPM on long term motor and sensory outcomes. The effect of two types of TPM on long-term pain and functional independence outcomes.\n\nHow safe TPM is for participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Acute traumatic spinal cord injury (SCI) involving neurological levels as defined by the ASIA neurological examination between C0 and T8 (tetraplegia) and resulting in new onset neurological deficits consistent with an ASIA motor assessment of level A, B or C.\n2. Subject is 18 years of age or older.\n\nExclusion Criteria:\n\n1. Penetrating SCI injury.\n2. Isolated cauda equina syndrome or injury at bony level Th9 or below.\n3. Pre-existing motor deficit secondary to chronic myelopathy.\n4. History of demyelinating disease or central nervous system autoimmune disorder.\n5. History within the past six months and/or physical findings on admission of decompensated congestive heart failure (NYHA functional class III or IV, or objective class C or D).\n6. Acute, evolving or recent (30 days) myocardial infarction.\n7. Chronic renal failure requiring dialysis.\n8. Suspected or confirmed pregnancy.\n9. Severe terminal disease with life expectancy less than 6 months.\n10. Severe traumatic brain injury at presentation (GCS ≤8) with confirmation of injury on brain imaging.\n11. A condition that would preclude the performance of an accurate neurological exam due to a prior diagnosis of Alzheimer's disease, stroke, degenerative condition, cerebral tumor, or mental retardation.\n12. Non-English or Non-Spanish Speaking.\n13. Refusal of consent."}, 'identificationModule': {'nctId': 'NCT02878850', 'acronym': 'TEMPLE', 'briefTitle': 'Randomized Trial of Early Hemodynamic Management of Patients Following Acute Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Randomized Trial of Early Hemodynamic Management of Patients Following Acute Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'TEMPLE - 001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Augmented Blood Pressure', 'description': 'Subjects will have their blood pressure kept in a higher range.', 'interventionNames': ['Other: Augmented Blood Pressure']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional Blood Pressure', 'description': 'Subjects will have their blood pressure kept in a normal range.'}], 'interventions': [{'name': 'Augmented Blood Pressure', 'type': 'OTHER', 'description': 'Subjects will have their blood pressure kept in a higher range.', 'armGroupLabels': ['Augmented Blood Pressure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Atrium Health F.H. Sammy Ross Trauma Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Atrium Health Wake Forest Baptist', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati Medical Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Health System', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Miriam Treggiari, MD, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Miriam Treggiari', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}