COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted/resubmitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03309579




Registration number
NCT03309579
Ethics application status
Date submitted
10/10/2017
Date registered
13/10/2017
Date last updated
29/05/2020

Titles & IDs
Public title
SAHaRA: A Randomized Controlled Trial
Scientific title
Aneurysmal Subarachnoid Hemorrhage - Red Blood Cell Transfusion and Outcome (SAHaRA): A Randomized Controlled Trial
Secondary ID [1] 0 0
CTO:903
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subarachnoid Hemorrhage, Aneurysmal 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Liberal RBC Transfusion Strategy
Other interventions - Restrictive RBC Transfusion Strategy

Experimental: Liberal RBC Transfusion Strategy - Hemoglobin value of =100g/L

Active Comparator: Restrictive RBC Transfusion Strategy - Hemoglobin value of =80g/L


Other interventions: Liberal RBC Transfusion Strategy
RBC transfusion is triggered by a Hemoglobin value of =100g/L

Other interventions: Restrictive RBC Transfusion Strategy
Optional RBC transfusion is triggered by a Hemoglobin value of =80g/L

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
12 months post
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
12 months post
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
12 months post
Secondary outcome [3] 0 0
Red Blood Cell Transfusions - The total number of red blood cell transfusions received.
Timepoint [3] 0 0
up to 21 days
Secondary outcome [4] 0 0
Daily Hemoglobin - The lowest daily hemoglobin values.
Timepoint [4] 0 0
up to 21 days
Secondary outcome [5] 0 0
Transfusion-related Complications - Complications such as Acute Respiratory Distress Syndrome (ARDS), cardiovascular failure, cardiac ischemia, deep venous thrombosis, pulmonary embolism, sepsis, and septic shock.
Timepoint [5] 0 0
up to 28 days
Secondary outcome [6] 0 0
Delayed Cerebral Ischemia and Vasospasm - The incidence and severity of delayed cerebral ischemia and vasospasm.
Timepoint [6] 0 0
up to 28 days
Secondary outcome [7] 0 0
Cerebral Infarction - The incidence of cerebral infarctions.
Timepoint [7] 0 0
up to 28 days
Secondary outcome [8] 0 0
Mechanical Ventilation - If required, the duration of mechanical ventilation.
Timepoint [8] 0 0
up to 21 days
Secondary outcome [9] 0 0
Length of Stay - The length of ICU or hospital stay.
Timepoint [9] 0 0
12 months post
Secondary outcome [10] 0 0
Mortality - The number of deaths.
Timepoint [10] 0 0
12 months post

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The George Institute - Newtown
Recruitment postcode(s) [1] 0 0
- Newtown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
Canada
State/province [2] 0 0
Alberta
Country [3] 0 0
Canada
State/province [3] 0 0
British Columbia
Country [4] 0 0
Canada
State/province [4] 0 0
Manitoba
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Other
Name
Ottawa Hospital Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Canadian Institutes of Health Research (CIHR)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03309579
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Shane English, MD MSc FRCPC
Address 0 0
Ottawa Hospital Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Shane English, MD MSc FRCPC
Address 0 0
Country 0 0
Phone 0 0
(613) 737-8899
Fax 0 0
Email 0 0
senglish@toh.ca
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03309579