Status:
COMPLETED
SAHaRA: A Randomized Controlled Trial
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Subarachnoid Hemorrhage, Aneurysmal
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The SAHaRA trial will clarify the role of treating anemia with Red Blood Cell (RBC) transfusion in a unique and vulnerable patient population, and determine whether that impacts on functional outcomes...
Detailed Description
We hypothesize that in adult patients suffering from aSAH and anemia, a liberal RBC transfusion strategy as compared to a restrictive RBC transfusion strategy decreases the combined rate of death and ...
Eligibility Criteria
Inclusion
- Age ≥18 years old at time of SAH
- First ever episode of aneurysmal SAH
- Diagnosis of aSAH as confirmed by treating physician (eg: neurosurgeon or neuro- interventionalist) and supported by blood in subarachnoid space (e.g. cranial imaging or cerebrospinal fluid positive for xanthochromia, surgical visualization) that is the result of a ruptured aneurysm (e.g. direct visualization, cranial imaging or catheter angiogram)
- Hb ≤100g/L within 10 days following aSAH (defined by first day of hospital presentation)
Exclusion
- Physician and or family decision to withdraw/withhold active medical care at time of enrolment
- Active bleeding with hemodynamic instability at time of enrolment
- Patients with contraindication or known objection to blood transfusions
- SAH due to mycotic aneurysm, infundibulum and vascular malformations.
Key Trial Info
Start Date :
February 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2024
Estimated Enrollment :
742 Patients enrolled
Trial Details
Trial ID
NCT03309579
Start Date
February 12 2018
End Date
August 22 2024
Last Update
November 6 2024
Active Locations (23)
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1
University of Colorado School of Medicine
Aurora, Colorado, United States, 80045
2
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
3
Rush University Medical Center
Chicago, Illinois, United States, 60612
4
Nepean Hospital
Kingswood, New South Wales, Australia