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SAHaRA: A Randomized Controlled Trial

Primary Purpose

Subarachnoid Hemorrhage, Aneurysmal

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Liberal RBC Transfusion Strategy
Restrictive RBC Transfusion Strategy
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subarachnoid Hemorrhage, Aneurysmal focused on measuring Aneurysmal subarachnoid hemorrhage (aSAH), Red Blood Cell Transfusion (RBC), Vasospasm, Intracranial Hemorrhages, Cardiovascular Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Emory University School of MedicineRecruiting
  • Rush University Medical CenterRecruiting
  • The George InstituteRecruiting
  • Foothills Medical CenterRecruiting
  • University of Alberta HospitalRecruiting
  • Vancouver General HospitalRecruiting
  • Royal Jubilee HospitalRecruiting
  • Winnipeg Health Sciences CenterRecruiting
  • Hamilton Health Sciences CenterRecruiting
  • Kingston Health Sciences CentreRecruiting
  • London Health Sciences CenterRecruiting
  • Shane EnglishRecruiting
  • Sunnybrook Research InstituteRecruiting
  • Centre hospitalier de l'Université de MontréalRecruiting
  • Montreal Neurological Institute and HospitalRecruiting
  • Centre hospitalier universitaire de Québec-Université LavalRecruiting
  • Centre hospitalier universitaire de SherbrookeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Liberal RBC Transfusion Strategy

Restrictive RBC Transfusion Strategy

Arm Description

Hemoglobin value of ≤100g/L

Hemoglobin value of ≤80g/L

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Red Blood Cell Transfusions
The total number of red blood cell transfusions received.
Daily Hemoglobin
The lowest daily hemoglobin values.
Transfusion-related Complications
Complications such as Acute Respiratory Distress Syndrome (ARDS), cardiovascular failure, cardiac ischemia, deep venous thrombosis, pulmonary embolism, sepsis, and septic shock.
Delayed Cerebral Ischemia and Vasospasm
The incidence and severity of delayed cerebral ischemia and vasospasm.
Cerebral Infarction
The incidence of cerebral infarctions.
Mechanical Ventilation
If required, the duration of mechanical ventilation.
Length of Stay
The length of ICU or hospital stay.
Mortality
The number of deaths.

Full Information

First Posted
October 10, 2017
Last Updated
April 20, 2023
Sponsor
Ottawa Hospital Research Institute
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT03309579
Brief Title
SAHaRA: A Randomized Controlled Trial
Official Title
Aneurysmal Subarachnoid Hemorrhage - Red Blood Cell Transfusion and Outcome (SAHaRA): A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage, Aneurysmal
Keywords
Aneurysmal subarachnoid hemorrhage (aSAH), Red Blood Cell Transfusion (RBC), Vasospasm, Intracranial Hemorrhages, Cardiovascular Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicentre pragmatic, open-label blinded-endpoint
Masking
Outcomes Assessor
Masking Description
open-label blinded-endpoint
Allocation
Randomized
Enrollment
740 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liberal RBC Transfusion Strategy
Arm Type
Experimental
Arm Description
Hemoglobin value of ≤100g/L
Arm Title
Restrictive RBC Transfusion Strategy
Arm Type
Active Comparator
Arm Description
Hemoglobin value of ≤80g/L
Intervention Type
Other
Intervention Name(s)
Liberal RBC Transfusion Strategy
Intervention Description
RBC transfusion is triggered by a Hemoglobin value of ≤100g/L
Intervention Type
Other
Intervention Name(s)
Restrictive RBC Transfusion Strategy
Intervention Description
Optional RBC transfusion is triggered by a Hemoglobin value of ≤80g/L
Primary Outcome Measure Information:
Title
Modified Rankin Scale (mRS)
Description
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.
Time Frame
12 months post
Secondary Outcome Measure Information:
Title
Functional Independence Measure (FIM)
Description
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.
Time Frame
12 months post
Title
EuroQOL Quality of Life Scale (EQ5D)
Description
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.
Time Frame
12 months post
Title
Red Blood Cell Transfusions
Description
The total number of red blood cell transfusions received.
Time Frame
up to 21 days
Title
Daily Hemoglobin
Description
The lowest daily hemoglobin values.
Time Frame
up to 21 days
Title
Transfusion-related Complications
Description
Complications such as Acute Respiratory Distress Syndrome (ARDS), cardiovascular failure, cardiac ischemia, deep venous thrombosis, pulmonary embolism, sepsis, and septic shock.
Time Frame
up to 28 days
Title
Delayed Cerebral Ischemia and Vasospasm
Description
The incidence and severity of delayed cerebral ischemia and vasospasm.
Time Frame
up to 28 days
Title
Cerebral Infarction
Description
The incidence of cerebral infarctions.
Time Frame
up to 28 days
Title
Mechanical Ventilation
Description
If required, the duration of mechanical ventilation.
Time Frame
up to 21 days
Title
Length of Stay
Description
The length of ICU or hospital stay.
Time Frame
12 months post
Title
Mortality
Description
The number of deaths.
Time Frame
12 months post

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shane English, MD MSc FRCPC
Phone
(613) 737-8899
Ext
72818
Email
senglish@toh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shane English, MD MSc FRCPC
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
The George Institute
City
Newtown
State/Province
New South Wales
Country
Australia
Individual Site Status
Recruiting
Facility Name
Foothills Medical Center
City
Calgary
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Individual Site Status
Recruiting
Facility Name
Royal Jubilee Hospital
City
Victoria
State/Province
British Columbia
Country
Canada
Individual Site Status
Recruiting
Facility Name
Winnipeg Health Sciences Center
City
Winnipeg
State/Province
Manitoba
Country
Canada
Individual Site Status
Recruiting
Facility Name
Hamilton Health Sciences Center
City
Hamilton
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Name
Kingston Health Sciences Centre
City
Kingston
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Name
London Health Sciences Center
City
London
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Name
Shane English
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shane English, MD MSc FRCPC
Phone
613-737-8899
Ext
72818
Email
senglish@ohri.ca
Facility Name
Sunnybrook Research Institute
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre hospitalier de l'Université de Montréal
City
Montréal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Name
Montreal Neurological Institute and Hospital
City
Montréal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre hospitalier universitaire de Québec-Université Laval
City
Québec City
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre hospitalier universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34932836
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.
Results Reference
derived

Learn more about this trial

SAHaRA: A Randomized Controlled Trial

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