SAHaRA: A Randomized Controlled Trial

  • STATUS
    Recruiting
  • End date
    Sep 4, 2021
  • participants needed
    740
  • sponsor
    Ottawa Hospital Research Institute
Updated on 4 June 2020
Investigator
Shane English, MD MSc FRCPC
Primary Contact
The George Institute (8.0 mi away) Contact
+14 other location

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 and mortality. It will guide best practice standards and clarify the optimal RBC transfusion strategy in patients with aSAH.

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 severe disability at 12 months (using the modified Rankin Scale)

Details
Treatment Liberal RBC Transfusion Strategy, Restrictive RBC Transfusion Strategy
Clinical Study IdentifierNCT03309579
SponsorOttawa Hospital Research Institute
Last Modified on4 June 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Subarachnoid Hemorrhage?
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 neurointerventionalist) 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 Criteria

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
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