Clinical trial NCT03309579: SAHaRA: A Randomized Controlled Trial
Official title: Aneurysmal Subarachnoid Hemorrhage - Red Blood Cell Transfusion and Outcome (SAHaRA): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subarachnoid Hemorrhage, Aneurysmal
Keywords: Aneurysmal subarachnoid hemorrhage (aSAH)
Red Blood Cell Transfusion (RBC)
Vasospasm
Intracranial Hemorrhages
Cardiovascular Diseases
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2017-10-13
Enrollment: 742
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentre pragmatic, open-label blinded-endpoint
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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. 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)
4. Hb ≤100g/L within 10 days following aSAH (defined by first day of hospital presentation)

Exclusion Criteria:

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

Primary outcomes:
measure: Modified Rankin Scale (mRS)
timeFrame: 12 months post
Secondary outcomes:
measure: Functional Independence Measure (FIM)
timeFrame: 12 months post
measure: EuroQOL Quality of Life Scale (EQ5D)
timeFrame: 12 months post
measure: Red Blood Cell Transfusions
timeFrame: up to 21 days
measure: Daily Hemoglobin
timeFrame: up to 21 days
measure: Transfusion-related Complications
timeFrame: up to 28 days
measure: Delayed Cerebral Ischemia and Vasospasm
timeFrame: up to 28 days
measure: Cerebral Infarction
timeFrame: up to 28 days
measure: Mechanical Ventilation
timeFrame: up to 21 days
measure: Length of Stay
timeFrame: 12 months post
measure: Mortality
timeFrame: 12 months post
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado School of Medicine
state: Colorado
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: St. Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane & Women's Hospital
state: Queensland
city: Melbourne
country: Australia
facility: The Alfred
state: Victoria
city: Calgary
country: Canada
facility: Foothills Medical Center
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Royal Jubilee Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Health Sciences Center
state: Manitoba
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Center
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences Center
state: Ontario
city: Ottawa
country: Canada
facility: Shane English
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontario
city: Montréal
country: Canada
facility: Centre hospitalier de l'Université de Montréal
state: Quebec
city: Montréal
country: Canada
facility: Montreal Neurological Institute and Hospital
state: Quebec
city: Québec City
country: Canada
facility: Centre hospitalier universitaire de Québec-Université Laval
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Shane English, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.