Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2026-02-23 @ 4:55 AM
Study NCT ID:
NCT01023893
Status:
UNKNOWN
Last Update Posted:
2009-12-02
First Post:
2009-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Viscosity, End-Stage Renal Disease, And Mortality (BEAM-1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'lastUpdateSubmitDate': '2009-12-01', 'studyFirstSubmitDate': '2009-12-01', 'studyFirstSubmitQcDate': '2009-12-01', 'lastUpdatePostDateStruct': {'date': '2009-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular mortality', 'timeFrame': 'One year'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': 'One year'}, {'measure': 'Vascular access thrombosis', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Renal Replacement Therapy']}, 'referencesModule': {'references': [{'pmid': '19670184', 'type': 'BACKGROUND', 'citation': 'Vaisman S, Kensey K, Cho YI. Effect of hemodialysis on whole blood viscosity. Int J Artif Organs. 2009 Jun;32(6):329-35. doi: 10.1177/039139880903200603.'}, {'pmid': '9012704', 'type': 'BACKGROUND', 'citation': 'Lowe GD, Lee AJ, Rumley A, Price JF, Fowkes FG. Blood viscosity and risk of cardiovascular events: the Edinburgh Artery Study. Br J Haematol. 1997 Jan;96(1):168-73. doi: 10.1046/j.1365-2141.1997.8532481.x.'}]}, 'descriptionModule': {'briefSummary': "Prospective, real-time observational study of hemodialysis patients treated with erythropoiesis-stimulating agents (ESA) to currently recommended Hgb targets. Subjects will be evaluated dynamically for their blood viscosity status at the beginning and end of the dialysis treatment, and followed prospectively to assess outcomes. Blood specimens will be collected via the subject's hemodialysis port pre- and post-hemodialysis per study assessment visit. Blood will be analyzed at a designated laboratory facility for viscosity over a comprehensive range of shear rates and tested for intradialytic surges in blood viscosity. Subjects will be followed for 48 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Dialysis clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years old\n* On hemodialysis \\> 3 months\n* On ESA treatment \\> 3 months\n* Mean Hgb 11 g/dL - 12 g/dL (based on at least 3 Hgb results during the previous 8 weeks)\n* Latest Hgb 10.5 g/dL - 12.5 g/dL (measured within 1 week of study)\n\nExclusion Criteria:\n\n* Inability or unwillingness to provide informed consent\n* Large variability in interdialytic weight gain (\\>2 kg difference between low and high weight gain over last month)\n* More than 1 missed dialysis treatments in past month\n* Recent bleeding\n* Blood transfusion within 1 month\n* Hematologic disease other than anemia\n* Active inflammatory disease\n* Active infection'}, 'identificationModule': {'nctId': 'NCT01023893', 'acronym': 'BEAM-1', 'briefTitle': 'Blood Viscosity, End-Stage Renal Disease, And Mortality (BEAM-1)', 'organization': {'class': 'INDUSTRY', 'fullName': 'ProMetrics, Inc.'}, 'officialTitle': 'Clinical Diagnostic Evaluation Study of Blood Viscosity, End-Stage Renal Disease, And Mortality', 'orgStudyIdInfo': {'id': 'PRO-0062-201'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'End-stage renal disease'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ProMetrics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Daniel Cho, VP Lab Services', 'oldOrganization': 'ProMetrics'}}}}