Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2025-12-24 @ 11:51 AM
Study NCT ID:
NCT01011361
Status:
COMPLETED
Last Update Posted:
2016-03-24
First Post:
2009-11-09
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Red Cell Mass and Plasma Volume Measurements in Elderly Men and Women With Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-23', 'studyFirstSubmitDate': '2009-11-09', 'studyFirstSubmitQcDate': '2009-11-09', 'lastUpdatePostDateStruct': {'date': '2016-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Red blood cell mass', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Plasma volume measurements', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anemia']}, 'descriptionModule': {'briefSummary': 'On the basis that the clinical consequences of seemingly trivial levels of anemia are surprisingly severe, this study investigates if hemoglobin concentration accurately represents the underlying red cell mass in elderly patients with unresolved anemia.', 'detailedDescription': 'For the study, the routine clinical measurement of hemoglobin will be compared to true red cell mass and plasma volume in elderly patients with anemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatient elderly men and women (aged 65 years or older) with anemia, also enrolled in the "Anemia in the Elderly" NCT00640172 study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\n* 65 and older\n* Anemia (hemoglobin \\< 13 g/dL in men or \\< 12 g/dL in women)\n* Outpatient at either the Stanford Health Care (SHC) Medical Center or VA Palo Alto Health Care System\n\nEXCLUSION CRITERIA:\n\n* Body mass index (BMI):\n\n * \\< 18.5 kg/m2\n * \\> 35 kg/m2\n* Palpable splenomegaly\n* Contraindication to RBC mass/plasma volume testing\n* On any experimental pharmacologic agent in the prior 2 months'}, 'identificationModule': {'nctId': 'NCT01011361', 'briefTitle': 'Red Cell Mass and Plasma Volume Measurements in Elderly Men and Women With Anemia', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Red Cell Mass and Plasma Volume Measurements in Elderly Men and Women With Anemia', 'orgStudyIdInfo': {'id': 'IRB-16209'}, 'secondaryIdInfos': [{'id': 'SU-07302009-3480', 'type': 'OTHER', 'domain': 'Stanford University'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Stanley L Schrier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine (Hematology), Emeritus', 'investigatorFullName': 'Stanley L Schrier', 'investigatorAffiliation': 'Stanford University'}}}}