Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-01-01 @ 7:25 AM
Study NCT ID:
NCT02483351
Status:
COMPLETED
Last Update Posted:
2018-04-04
First Post:
2015-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aneurysmal Subarachnoid Hemorrhage: Red Blood Cell Transfusion and Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-03', 'studyFirstSubmitDate': '2015-06-25', 'studyFirstSubmitQcDate': '2015-06-25', 'lastUpdatePostDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Randomization Rate', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Blood Transfusion'], 'conditions': ['Subarachnoid Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '41114449', 'type': 'DERIVED', 'citation': 'Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.'}, {'pmid': '34932836', 'type': 'DERIVED', 'citation': 'Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.'}, {'pmid': '27927658', 'type': 'DERIVED', 'citation': 'English SW, Fergusson D, Chasse M, Turgeon AF, Lauzier F, Griesdale D, Algird A, Kramer A, Tinmouth A, Lum C, Sinclair J, Marshall S, Dowlatshahi D, Boutin A, Pagliarello G, McIntyre LA; Canadian Critical Care Trials Group. Aneurysmal SubArachnoid Hemorrhage-Red Blood Cell Transfusion And Outcome (SAHaRA): a pilot randomised controlled trial protocol. BMJ Open. 2016 Dec 7;6(12):e012623. doi: 10.1136/bmjopen-2016-012623.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the feasibility of conducting a large trial examining the effect on clinical outcome of a liberal red blood cell (RBC) transfusion strategy compared to a restrictive strategy (usual care) in patients with aneurysmal subarachnoid hemorrhage (SAH).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years old at time of presentation\n2. First ever episode aneurysmal SAH\n3. Confirmed aneurysmal SAH diagnosis: as confirmed by treating Neurosurgeon or Neuro-interventionalist and supported by blood in subarachnoid space (demonstrated on cranial imaging or cerebrospinal fluid positive for xanthochromia) that is the result of a ruptured saccular aneurysm (confirmed by cranial imaging - cranial topography or magnetic resonance imaging angiography or catheter angiogram)\n4. Incident hemoglobin ≤100g/L within 14 days following SAH (defined by first day of hospital presentation)\n\nExclusion Criteria:\n\n1. Physician and or family decision to withdraw/withhold critical care at time of enrolment\n2. Active bleeding with hemodynamic instability at time of enrolment\n3. Patients with contra-indication or known objection to blood transfusions\n4. SAH due to causes other than saccular aneurysm rupture including mycotic, traumatic and dissecting aneurysms, and aneurysms associated with arteriovenous malformations.'}, 'identificationModule': {'nctId': 'NCT02483351', 'acronym': 'SAHaRA Pilot', 'briefTitle': 'Aneurysmal Subarachnoid Hemorrhage: Red Blood Cell Transfusion and Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'Aneurysmal Subarachnoid Hemorrhage: Red Blood Cell Transfusion and Outcome - A Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '20150433-01H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liberal RBC Transfusion Strategy', 'interventionNames': ['Other: Liberal Red Blood Cell Transfusion Strategy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Restrictive RBC Transfusion Strategy', 'interventionNames': ['Other: Restrictive Red Blood Cell Transfusion Strategy']}], 'interventions': [{'name': 'Liberal Red Blood Cell Transfusion Strategy', 'type': 'OTHER', 'description': 'RBC Transfusion strategy with hemoglobin trigger of 100g/L', 'armGroupLabels': ['Liberal RBC Transfusion Strategy']}, {'name': 'Restrictive Red Blood Cell Transfusion Strategy', 'type': 'OTHER', 'description': 'Optional RBC Transfusion with hemoglobin trigger of \\<=80g/L', 'armGroupLabels': ['Restrictive RBC Transfusion Strategy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Health Sciences Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K1Y 4E9', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Shane English', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Shane English, MD MSc FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Hospital Research Institute'}, {'name': 'Lauralyn McIntyre, MD MSc FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Hospital Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Scientist', 'investigatorFullName': 'Shane English', 'investigatorAffiliation': 'Ottawa Hospital Research Institute'}}}}