SAHaRA: A Randomized Controlled Trial

NCT03309579 | Completed DMC

• 1 other identifier: CTO:903
• Study Type: interventional
• Target: 742
• Locations: 3 countries
• Sites: 23

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

Conditions

Subarachnoid Hemorrhage, Aneurysmal

Keywords

Aneurysmal subarachnoid hemorrhage (aSAH); Red Blood Cell Transfusion (RBC); Vasospasm; Intracranial Hemorrhages; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale (mRS)

  The Modified Rankin Scale (mRS) is a functional outcome measure in stroke. The interview consists of five sections: Constant Care, Assistance to Attend to Bodily Needs/For Walking, Assistance to Look After Own Affairs, Usual Duties and Activities and Symptoms as a Result of Stroke. The scale is scored from 0 reporting no symptoms at all, to 5 reporting severe disability. Death is indicated by a score of 6.

  12 months post

Secondary Outcomes (10)

• Functional Independence Measure (FIM)

  12 months post

• EuroQOL Quality of Life Scale (EQ5D)

  12 months post

• Red Blood Cell Transfusions

  up to 21 days

• Daily Hemoglobin

  up to 21 days

• Transfusion-related Complications

  up to 28 days

Study Arms (2)

Liberal RBC Transfusion Strategy

EXPERIMENTAL

Hemoglobin value of ≤100g/L

Other: Liberal RBC Transfusion Strategy

Restrictive RBC Transfusion Strategy

ACTIVE COMPARATOR

Hemoglobin value of ≤80g/L

Other: Restrictive RBC Transfusion Strategy

Interventions

Liberal RBC Transfusion Strategy OTHER

RBC transfusion is triggered by a Hemoglobin value of ≤100g/L

Liberal RBC Transfusion Strategy

Restrictive RBC Transfusion Strategy OTHER

Optional RBC transfusion is triggered by a Hemoglobin value of ≤80g/L

Restrictive RBC Transfusion Strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (23)

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Nepean Hospital

Kingswood, New South Wales, Australia

Location

Prince of Wales Hospital

Randwick, New South Wales, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Location

Royal Brisbane & Women's Hospital

Herston, Queensland, Australia

Location

The Alfred

Melbourne, Victoria, Australia

Location

Foothills Medical Center

Calgary, Alberta, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

Royal Jubilee Hospital

Victoria, British Columbia, Canada

Location

Winnipeg Health Sciences Center

Winnipeg, Manitoba, Canada

Location

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

Location

Hamilton Health Sciences Center

Hamilton, Ontario, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Location

London Health Sciences Center

London, Ontario, Canada

Location

Shane English

Ottawa, Ontario, K1Y 4E9, Canada

Location

Sunnybrook Research Institute

Toronto, Ontario, Canada

Location

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Location

Montreal Neurological Institute and Hospital

Montreal, Quebec, Canada

Location

Centre hospitalier universitaire de Québec-Université Laval

Québec, Quebec, Canada

Location

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Location

Related Publications (3)

• 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: 41114449 DERIVED

• English SW, Delaney A, Fergusson DA, Chasse M, Turgeon AF, Lauzier F, Tuttle A, Sadan O, Griesdale DE, Redekop G, Chapman M, Hannouche M, Kramer A, Seppelt I, Udy A, Kutsogiannis DJ, Zarychanski R, D'Aragon F, Boyd JG, Salt G, Bellapart J, Wood G, Cava L, Pickett G, Koffman L, Watpool I, Bass F, Hammond N, Ramsay T, Mallick R, Scales DC, Andersen CR, Fitzgerald E, Talbot P, Dowlatshahi D, Sinclair J, Acker J, Marshall SC, McIntyre L; SAHARA Trial Investigators on behalf of the Canadian Critical Care Trials Group; Canadian Critical Care Trials Group. Liberal or Restrictive Transfusion Strategy in Aneurysmal Subarachnoid Hemorrhage. N Engl J Med. 2025 Mar 13;392(11):1079-1088. doi: 10.1056/NEJMoa2410962. Epub 2024 Dec 9.

  PMID: 39655786 DERIVED

• 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: 34932836 DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Intracranial Hemorrhages; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shane English, MD MSc FRCPC

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: open-label blinded-endpoint
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentre pragmatic, open-label blinded-endpoint

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 13, 2017
• Study Start: February 12, 2018
• Primary Completion: July 10, 2024
• Study Completion: August 22, 2024
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5); CA (15); US (3)