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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03309579
Ethics application status
Date submitted
10/10/2017
Date registered
13/10/2017

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)
Timepoint [1] 0 0
12 months post
Secondary outcome [1] 0 0
Functional Independence Measure (FIM)
Timepoint [1] 0 0
12 months post
Secondary outcome [2] 0 0
EuroQOL Quality of Life Scale (EQ5D)
Timepoint [2] 0 0
12 months post
Secondary outcome [3] 0 0
Red Blood Cell Transfusions
Timepoint [3] 0 0
up to 21 days
Secondary outcome [4] 0 0
Daily Hemoglobin
Timepoint [4] 0 0
up to 21 days
Secondary outcome [5] 0 0
Transfusion-related Complications
Timepoint [5] 0 0
up to 28 days
Secondary outcome [6] 0 0
Delayed Cerebral Ischemia and Vasospasm
Timepoint [6] 0 0
up to 28 days
Secondary outcome [7] 0 0
Cerebral Infarction
Timepoint [7] 0 0
up to 28 days
Secondary outcome [8] 0 0
Mechanical Ventilation
Timepoint [8] 0 0
up to 21 days
Secondary outcome [9] 0 0
Length of Stay
Timepoint [9] 0 0
12 months post
Secondary outcome [10] 0 0
Mortality
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
Sex
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
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2024
Actual
Sample size
Target
740
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
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
Canada
State/province [3] 0 0
Alberta
Country [4] 0 0
Canada
State/province [4] 0 0
British Columbia
Country [5] 0 0
Canada
State/province [5] 0 0
Manitoba
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Other
Name
Ottawa Hospital Research Institute
Address
Country
Other collaborator category [1] 0 0
Government body
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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03309579