SAHaRA: A Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Subarachnoid Hemorrhage, Aneurysmal
• Interventions: Other: Liberal RBC Transfusion Strategy; Other: Restrictive RBC Transfusion Strategy

• Registration Number: NCT03309579
• Lead Sponsor: Ottawa Hospital Research Institute

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)

Study Timeline

• Study First Submitted: 2017-10-10
• Study First Submitted QC: 2017-10-10
• Study First Posted: 2017-10-13
• Study Start: 2018-02-12
• Primary Completion: 2024-07-10
• Study Completion: 2024-08-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 742

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liberal RBC Transfusion Strategy	Liberal RBC Transfusion Strategy	Hemoglobin value of ≤100g/L
Restrictive RBC Transfusion Strategy	Restrictive RBC Transfusion Strategy	Hemoglobin value of ≤80g/L

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale (mRS)	12 months post	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.

Secondary Outcome Measures

Name	Time	Method
Delayed Cerebral Ischemia and Vasospasm	up to 28 days	The incidence and severity of delayed cerebral ischemia and vasospasm.
Mortality	12 months post	The number of deaths.
Mechanical Ventilation	up to 21 days	If required, the duration of mechanical ventilation.
Length of Stay	12 months post	The length of ICU or hospital stay.
Transfusion-related Complications	up to 28 days	Complications such as Acute Respiratory Distress Syndrome (ARDS), cardiovascular failure, cardiac ischemia, deep venous thrombosis, pulmonary embolism, sepsis, and septic shock.
Functional Independence Measure (FIM)	12 months post	The Functional Independence Measure (FIM) assesses the level of a patient's disability considering the amount of support needed to care for them.Items are scored on the basis of how much assistance is required for the individual to carry out activities of daily living.; The FIM is comprised of 18 items, grouped into 2 subscales - motor and cognition.; Each item is scored on a 7 point ordinal scale, ranging from 1 to 7. The 2 subscales are then added to give a total FIM score between 18 and 126. The higher the score, the more independent the patient is in performing activities of daily living.
Red Blood Cell Transfusions	up to 21 days	The total number of red blood cell transfusions received.
Cerebral Infarction	up to 28 days	The incidence of cerebral infarctions.
EuroQOL Quality of Life Scale (EQ5D)	12 months post	The EQ-5D measures generic health status. There are 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort and Anxiety/Depression which are answered by 5 Problem Levels: None, Slight, Moderate, Severe and Unable. The result is a 5 digit number, 11111 indicating no problem in any dimension to 55555 indicating unable to complete in all dimensions.; Quality of life is also assessed on a visual analog scale reported from 0 being the worst imaginable health status to 100 as the best imaginable health status.
Daily Hemoglobin	up to 21 days	The lowest daily hemoglobin values.

Trial Locations

Locations (23)

University of Colorado School of Medicine; 🇺🇸 Aurora, Colorado, United States

Nepean Hospital; 🇦🇺 Kingswood, New South Wales, Australia

Prince of Wales Hospital; 🇦🇺 Randwick, New South Wales, Australia

Royal North Shore Hospital; 🇦🇺 St. Leonards, New South Wales, Australia

Royal Brisbane & Women's Hospital; 🇦🇺 Herston, Queensland, Australia

The Alfred; 🇦🇺 Melbourne, Victoria, Australia

Nova Scotia Health Authority; 🇨🇦 Halifax, Nova Scotia, Canada

Emory University School of Medicine; 🇺🇸 Atlanta, Georgia, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Foothills Medical Center; 🇨🇦 Calgary, Alberta, Canada

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Royal Jubilee Hospital; 🇨🇦 Victoria, British Columbia, Canada

Winnipeg Health Sciences Center; 🇨🇦 Winnipeg, Manitoba, Canada

Hamilton Health Sciences Center; 🇨🇦 Hamilton, Ontario, Canada

Montreal Neurological Institute and Hospital; 🇨🇦 Montréal, Quebec, Canada

Centre hospitalier universitaire de Québec-Université Laval; 🇨🇦 Québec City, Quebec, Canada

Centre hospitalier universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada

Kingston Health Sciences Centre; 🇨🇦 Kingston, Ontario, Canada

London Health Sciences Center; 🇨🇦 London, Ontario, Canada

Shane English; 🇨🇦 Ottawa, Ontario, Canada

Sunnybrook Research Institute; 🇨🇦 Toronto, Ontario, Canada

Centre hospitalier de l'Université de Montréal; 🇨🇦 Montréal, Quebec, Canada