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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03309579
Registration number
NCT03309579
Ethics application status
Date submitted
10/10/2017
Date registered
13/10/2017
Date last updated
6/06/2024
Titles & IDs
Public title
SAHaRA: A Randomized Controlled Trial
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Scientific title
Aneurysmal Subarachnoid Hemorrhage - Red Blood Cell Transfusion and Outcome (SAHaRA): A Randomized Controlled Trial
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Secondary ID [1]
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CTO:903
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Subarachnoid Hemorrhage, Aneurysmal
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Condition category
Condition code
Neurological
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Other neurological disorders
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Modified Rankin Scale (mRS)
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Assessment method [1]
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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.
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Timepoint [1]
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12 months post
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Secondary outcome [1]
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Functional Independence Measure (FIM)
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Assessment method [1]
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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.
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Timepoint [1]
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12 months post
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Secondary outcome [2]
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EuroQOL Quality of Life Scale (EQ5D)
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Assessment method [2]
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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.
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Timepoint [2]
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12 months post
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Secondary outcome [3]
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Red Blood Cell Transfusions
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Assessment method [3]
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The total number of red blood cell transfusions received.
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Timepoint [3]
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up to 21 days
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Secondary outcome [4]
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Daily Hemoglobin
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Assessment method [4]
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The lowest daily hemoglobin values.
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Timepoint [4]
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up to 21 days
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Secondary outcome [5]
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Transfusion-related Complications
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Assessment method [5]
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Complications such as Acute Respiratory Distress Syndrome (ARDS), cardiovascular failure, cardiac ischemia, deep venous thrombosis, pulmonary embolism, sepsis, and septic shock.
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Timepoint [5]
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up to 28 days
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Secondary outcome [6]
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Delayed Cerebral Ischemia and Vasospasm
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Assessment method [6]
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The incidence and severity of delayed cerebral ischemia and vasospasm.
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Timepoint [6]
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up to 28 days
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Secondary outcome [7]
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Cerebral Infarction
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Assessment method [7]
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The incidence of cerebral infarctions.
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Timepoint [7]
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up to 28 days
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Secondary outcome [8]
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Mechanical Ventilation
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Assessment method [8]
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If required, the duration of mechanical ventilation.
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Timepoint [8]
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up to 21 days
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Secondary outcome [9]
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Length of Stay
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Assessment method [9]
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The length of ICU or hospital stay.
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Timepoint [9]
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12 months post
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Secondary outcome [10]
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Mortality
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Assessment method [10]
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The number of deaths.
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Timepoint [10]
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12 months post
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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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/02/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/09/2024
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Actual
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Sample size
Target
740
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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The George Institute - Newtown
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Recruitment postcode(s) [1]
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- Newtown
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Georgia
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Country [2]
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United States of America
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State/province [2]
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Illinois
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Country [3]
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Canada
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State/province [3]
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Alberta
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Country [4]
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Canada
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State/province [4]
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British Columbia
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Country [5]
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Canada
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State/province [5]
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Manitoba
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Country [6]
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Canada
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State/province [6]
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Ontario
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Country [7]
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Canada
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State/province [7]
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Quebec
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Funding & Sponsors
Primary sponsor type
Other
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Name
Ottawa Hospital Research Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Canadian Institutes of Health Research (CIHR)
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03309579
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Shane English, MD MSc FRCPC
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Address
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Ottawa Hospital Research Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03309579
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