SAHaRA: A Randomized Controlled Trial

Aneurysmal Subarachnoid Hemorrhage - Red Blood Cell Transfusion and Outcome (SAHaRA): A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Subarachnoid Hemorrhage, Aneurysmal
• Intervention / Treatment: Other: Liberal RBC Transfusion Strategy; Other: Restrictive RBC Transfusion Strategy

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 Type: Interventional
• Enrollment (Anticipated): 740
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shane English, MD MSc FRCPC; Phone Number: 72818 (613) 737-8899; Email: senglish@toh.ca

Study Locations

• Australia
  • New South Wales
    • Newtown, New South Wales, Australia
      • Recruiting
      • The George Institute
• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Recruiting
      • Foothills Medical Center
    • Edmonton, Alberta, Canada
      • Recruiting
      • University of Alberta Hospital
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Recruiting
      • Vancouver General Hospital
    • Victoria, British Columbia, Canada
      • Recruiting
      • Royal Jubilee Hospital
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • Recruiting
      • Winnipeg Health Sciences Center
  • Ontario
    • Hamilton, Ontario, Canada
      • Recruiting
      • Hamilton Health Sciences Center
    • Kingston, Ontario, Canada
      • Recruiting
      • Kingston Health Sciences Centre
    • London, Ontario, Canada
      • Recruiting
      • London Health Sciences Center
    • Ottawa, Ontario, Canada, K1Y 4E9
      • Recruiting
      • Shane English
      • Contact: Shane English, MD MSc FRCPC; Phone Number: 72818 613-737-8899; Email: senglish@ohri.ca
    • Toronto, Ontario, Canada
      • Recruiting
      • Sunnybrook Research Institute
  • Quebec
    • Montréal, Quebec, Canada
      • Recruiting
      • Centre Hospitalier de l'Universite de Montreal
    • Montréal, Quebec, Canada
      • Recruiting
      • Montreal Neurological Institute and Hospital
    • Québec City, Quebec, Canada
      • Recruiting
      • Centre Hospitalier Universitaire de Québec-Université Laval
    • Sherbrooke, Quebec, Canada
      • Recruiting
      • Centre Hospitalier Universitaire de Sherbrooke
• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University School of Medicine
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liberal RBC Transfusion Strategy; Hemoglobin value of ≤100g/L	Other: Liberal RBC Transfusion Strategy; RBC transfusion is triggered by a Hemoglobin value of ≤100g/L
Active Comparator: Restrictive RBC Transfusion Strategy; Hemoglobin value of ≤80g/L	Other: Restrictive RBC Transfusion Strategy; Optional RBC transfusion is triggered by a Hemoglobin value of ≤80g/L

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Independence Measure (FIM)	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.	12 months post
EuroQOL Quality of Life Scale (EQ5D)	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.	12 months post
Red Blood Cell Transfusions	The total number of red blood cell transfusions received.	up to 21 days
Daily Hemoglobin	The lowest daily hemoglobin values.	up to 21 days
Transfusion-related Complications	Complications such as Acute Respiratory Distress Syndrome (ARDS), cardiovascular failure, cardiac ischemia, deep venous thrombosis, pulmonary embolism, sepsis, and septic shock.	up to 28 days
Delayed Cerebral Ischemia and Vasospasm	The incidence and severity of delayed cerebral ischemia and vasospasm.	up to 28 days
Cerebral Infarction	The incidence of cerebral infarctions.	up to 28 days
Mechanical Ventilation	If required, the duration of mechanical ventilation.	up to 21 days
Length of Stay	The length of ICU or hospital stay.	12 months post
Mortality	The number of deaths.	12 months post

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Shane English, MD MSc FRCPC, Ottawa Hospital Research Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2018
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: October 10, 2017
• First Submitted That Met QC Criteria: October 10, 2017
• First Posted (Actual): October 13, 2017

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Vasospasm; Aneurysmal subarachnoid hemorrhage (aSAH); Red Blood Cell Transfusion (RBC); Intracranial Hemorrhages
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Subarachnoid Hemorrhage
• Other Study ID Numbers: CTO:903

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No