SAHaRA: A Randomized Controlled Trial

Last updated: November 5, 2024
Sponsor: Ottawa Hospital Research Institute
Overall Status: Completed

Phase

N/A

Condition

Hemorrhage

Stroke

Treatment

Liberal RBC Transfusion Strategy

Restrictive RBC Transfusion Strategy

Clinical Study ID

NCT03309579
CTO:903
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years old at time of SAH

  2. First ever episode of aneurysmal SAH

  3. Diagnosis of aSAH as confirmed by treating physician (eg: neurosurgeon or neuro-interventionalist) and supported by blood in subarachnoid space (e.g. cranialimaging or cerebrospinal fluid positive for xanthochromia, surgical visualization)that is the result of a ruptured aneurysm (e.g. direct visualization, cranialimaging or catheter angiogram)

  4. Hb ≤100g/L within 10 days following aSAH (defined by first day of hospitalpresentation)

Exclusion

Exclusion Criteria:

  1. Physician and or family decision to withdraw/withhold active medical care at time ofenrolment

  2. Active bleeding with hemodynamic instability at time of enrolment

  3. Patients with contraindication or known objection to blood transfusions

  4. SAH due to mycotic aneurysm, infundibulum and vascular malformations.

Study Design

Total Participants: 742
Treatment Group(s): 2
Primary Treatment: Liberal RBC Transfusion Strategy
Phase:
Study Start date:
February 12, 2018
Estimated Completion Date:
August 22, 2024

Study 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)

Connect with a study center

  • Nepean Hospital

    Kingswood, New South Wales
    Australia

    Site Not Available

  • The George Institute

    Newtown, New South Wales
    Australia

    Site Not Available

  • Prince of Wales Hospital

    Randwick, New South Wales
    Australia

    Site Not Available

  • Royal North Shore Hospital

    St. Leonards, New South Wales
    Australia

    Site Not Available

  • Royal Brisbane & Women's Hospital

    Herston, Queensland
    Australia

    Site Not Available

  • The Alfred

    Melbourne, Victoria
    Australia

    Site Not Available

  • Foothills Medical Center

    Calgary, Alberta
    Canada

    Site Not Available

  • University of Alberta Hospital

    Edmonton, Alberta
    Canada

    Site Not Available

  • Vancouver General Hospital

    Vancouver, British Columbia
    Canada

    Site Not Available

  • Royal Jubilee Hospital

    Victoria, British Columbia
    Canada

    Site Not Available

  • Winnipeg Health Sciences Center

    Winnipeg, Manitoba
    Canada

    Site Not Available

  • Nova Scotia Health Authority

    Halifax, Nova Scotia
    Canada

    Site Not Available

  • Hamilton Health Sciences Center

    Hamilton, Ontario
    Canada

    Site Not Available

  • Kingston Health Sciences Centre

    Kingston, Ontario
    Canada

    Site Not Available

  • London Health Sciences Center

    London, Ontario
    Canada

    Site Not Available

  • Shane English

    Ottawa, Ontario K1Y 4E9
    Canada

    Site Not Available

  • Sunnybrook Research Institute

    Toronto, Ontario
    Canada

    Site Not Available

  • Centre hospitalier de l'Université de Montréal

    Montréal, Quebec
    Canada

    Site Not Available

  • Montreal Neurological Institute and Hospital

    Montréal, Quebec
    Canada

    Site Not Available

  • Centre hospitalier universitaire de Québec-Université Laval

    Québec City, Quebec
    Canada

    Site Not Available

  • Centre hospitalier universitaire de Sherbrooke

    Sherbrooke, Quebec
    Canada

    Site Not Available

  • University of Colorado School of Medicine

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Emory University School of Medicine

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

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