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Trial record 90 of 194 for:    Hemorrhage AND SAH

Aneurysmal Subarachnoid Hemorrhage: Red Blood Cell Transfusion and Outcome (SAHaRA Pilot)

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ClinicalTrials.gov Identifier: NCT02483351
Recruitment Status : Completed
First Posted : June 26, 2015
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Shane English, Ottawa Hospital Research Institute

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage Other: Liberal Red Blood Cell Transfusion Strategy Other: Restrictive Red Blood Cell Transfusion Strategy Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Aneurysmal Subarachnoid Hemorrhage: Red Blood Cell Transfusion and Outcome - A Pilot Randomized Controlled Trial
Study Start Date : October 2015
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Liberal RBC Transfusion Strategy Other: Liberal Red Blood Cell Transfusion Strategy
RBC Transfusion strategy with hemoglobin trigger of 100g/L

Active Comparator: Restrictive RBC Transfusion Strategy Other: Restrictive Red Blood Cell Transfusion Strategy
Optional RBC Transfusion with hemoglobin trigger of <=80g/L




Primary Outcome Measures :
  1. Randomization Rate [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years old at time of presentation
  2. First ever episode aneurysmal SAH
  3. 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)
  4. Incident hemoglobin ≤100g/L within 14 days following SAH (defined by first day of hospital presentation)

Exclusion Criteria:

  1. Physician and or family decision to withdraw/withhold critical care at time of enrolment
  2. Active bleeding with hemodynamic instability at time of enrolment
  3. Patients with contra-indication or known objection to blood transfusions
  4. SAH due to causes other than saccular aneurysm rupture including mycotic, traumatic and dissecting aneurysms, and aneurysms associated with arteriovenous malformations.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02483351


Locations
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Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada
Canada, Ontario
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada
Shane English
Ottawa, Ontario, Canada, K1Y 4E9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Shane English, MD MSc FRCPC Ottawa Hospital Research Institute
Principal Investigator: Lauralyn McIntyre, MD MSc FRCPC Ottawa Hospital Research Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shane English, Associate Scientist, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02483351     History of Changes
Other Study ID Numbers: 20150433-01H
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018

Keywords provided by Shane English, Ottawa Hospital Research Institute:
Blood Transfusion

Additional relevant MeSH terms:
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Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases