Subarachnoid Hemorrhage, AneurysmalNCT03309579
SAHaRA: A Randomized Controlled Trial
A study testing Liberal RBC Transfusion Strategy and Restrictive RBC Transfusion Strategy in people with Subarachnoid Hemorrhage, Aneurysmal, run by Ottawa Hospital Research Institute at 23 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal
- What is being tested?
- Liberal RBC Transfusion Strategy and Restrictive RBC Transfusion Strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 742 participants
- Where
- 23 sitesin 3 countries
- Study dates
- 12 Feb 2018to 22 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
23 sites in 3 countries.
23 sites in 3 countries
Canada15 sites
Foothills Medical Center
Calgary, Alberta
University of Alberta Hospital
Edmonton, Alberta
Nova Scotia Health Authority
Halifax, Nova Scotia
Hamilton Health Sciences Center
Hamilton, Ontario
Kingston Health Sciences Centre
Kingston, Ontario
London Health Sciences Center
London, Ontario
Centre hospitalier de l'Université de Montréal
Montreal, Quebec
Montreal Neurological Institute and Hospital
Montreal, Quebec
Shane English
Ottawa, Ontario, K1Y 4E9
Centre hospitalier universitaire de Québec-Université Laval
Québec, Quebec
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec
Sunnybrook Research Institute
Toronto, Ontario
Vancouver General Hospital
Vancouver, British Columbia
Royal Jubilee Hospital
Victoria, British Columbia
Winnipeg Health Sciences Center
Winnipeg, Manitoba
Australia5 sites
Royal Brisbane & Women's Hospital
Herston, Queensland
Nepean Hospital
Kingswood, New South Wales
The Alfred
Melbourne, Victoria
Prince of Wales Hospital
Randwick, New South Wales
Royal North Shore Hospital
St Leonards, New South Wales
United States3 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
University of Colorado School of Medicine
Aurora, Colorado, 80045
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: 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.
Read the 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)
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Being tested
- Liberal RBC Transfusion Strategy, Restrictive RBC Transfusion Strategy
- Keywords
- Aneurysmal subarachnoid hemorrhage (aSAH), Red Blood Cell Transfusion (RBC), Vasospasm, Intracranial Hemorrhages, Cardiovascular Diseases
- Medical subject headings
- Subarachnoid Hemorrhage, Intracranial Hemorrhages, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liberal RBC Transfusion StrategyOther
RBC transfusion is triggered by a Hemoglobin value of ≤100g/L
Restrictive RBC Transfusion StrategyOther
Optional RBC transfusion is triggered by a Hemoglobin value of ≤80g/L
| Study group | Role | What they receive |
|---|---|---|
| Liberal RBC Transfusion Strategy | Experimental | Hemoglobin value of ≤100g/L Receives: Other: Liberal RBC Transfusion Strategy |
| Restrictive RBC Transfusion Strategy | Active comparator | Hemoglobin value of ≤80g/L Receives: Other: Restrictive RBC Transfusion Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months post
Secondary outcomes (10)
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.
Measured: 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.
Measured: 12 months post
Red Blood Cell Transfusions
The total number of red blood cell transfusions received.
Measured: up to 21 days
Daily Hemoglobin
The lowest daily hemoglobin values.
Measured: 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.
Measured: up to 28 days
Delayed Cerebral Ischemia and Vasospasm
The incidence and severity of delayed cerebral ischemia and vasospasm.
Measured: up to 28 days
Cerebral Infarction
The incidence of cerebral infarctions.
Measured: up to 28 days
Mechanical Ventilation
If required, the duration of mechanical ventilation.
Measured: up to 21 days
Length of Stay
The length of ICU or hospital stay.
Measured: 12 months post
Mortality
The number of deaths.
Measured: 12 months post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study start12 Feb 2018
- Primary completion10 Jul 2024
- Study completion22 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid Hemorrhage, AneurysmalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre pragmatic, open-label blinded-endpoint
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 742 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Shane English, MD MSc FRCPC, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309579
- Sponsor's protocol ID
- CTO:903
- Status last verified
- Nov 2024
- First submitted
- 10 Oct 2017
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.
PubMed 41114449English SW, Delaney A, Fergusson DA, Chasse M, Turgeon AF, Lauzier F, Tuttle A, Sadan O, Griesdale DE, Redekop G, Chapman M, Hannouche M, Kramer A, Seppelt I, Udy A, Kutsogiannis DJ, Zarychanski R, D'Aragon F, Boyd JG, Salt G, Bellapart J, Wood G, Cava L, Pickett G, Koffman L, Watpool I, Bass F, Hammond N, Ramsay T, Mallick R, Scales DC, Andersen CR, Fitzgerald E, Talbot P, Dowlatshahi D, Sinclair J, Acker J, Marshall SC, McIntyre L; SAHARA Trial Investigators on behalf of the Canadian Critical Care Trials Group; Canadian Critical Care Trials Group. Liberal or Restrictive Transfusion Strategy in Aneurysmal Subarachnoid Hemorrhage. N Engl J Med. 2025 Mar 13;392(11):1079-1088. doi: 10.1056/NEJMoa2410962. Epub 2024 Dec 9.
PubMed 39655786Carson 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.
PubMed 34932836
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aneurysmal Subarachnoid Hemorrhage - Red Blood Cell Transfusion and Outcome (SAHaRA): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03309579
- Acronym / sponsor ID
- CTO:903
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Keywords
- Aneurysmal subarachnoid hemorrhage (aSAH), Red Blood Cell Transfusion (RBC), Vasospasm, Intracranial Hemorrhages, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 742 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 22 Aug 2024 (actual)
- First posted
- 13 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentre pragmatic, open-label blinded-endpoint
| Arm | Type | Receives |
|---|---|---|
| Liberal RBC Transfusion Strategy | Experimental | Other: Liberal RBC Transfusion StrategyHemoglobin value of ≤100g/L |
| Restrictive RBC Transfusion Strategy | Active comparator | Other: Restrictive RBC Transfusion StrategyHemoglobin value of ≤80g/L |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liberal RBC Transfusion StrategyRBC transfusion is triggered by a Hemoglobin value of ≤100g/L | Other | Liberal RBC Transfusion Strategy |
| Restrictive RBC Transfusion StrategyOptional RBC transfusion is triggered by a Hemoglobin value of ≤80g/L | Other | Restrictive RBC Transfusion Strategy |
Primary outcome
Modified Rankin Scale (mRS)
Time frame: 12 months post
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.
10 secondary outcomes
Functional Independence Measure (FIM)
Time frame: 12 months post
EuroQOL Quality of Life Scale (EQ5D)
Time frame: 12 months post
Red Blood Cell Transfusions
Time frame: up to 21 days
Daily Hemoglobin
Time frame: up to 21 days
Transfusion-related Complications
Time frame: up to 28 days
Delayed Cerebral Ischemia and Vasospasm
Time frame: up to 28 days
Cerebral Infarction
Time frame: up to 28 days
Mechanical Ventilation
Time frame: up to 21 days
Length of Stay
Time frame: 12 months post
Mortality
Time frame: 12 months post
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Derived from this study: PubMed 41114449Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.
- Derived from this study: PubMed 39655786English SW, Delaney A, Fergusson DA, Chasse M, Turgeon AF, Lauzier F, Tuttle A, Sadan O, Griesdale DE, Redekop G, Chapman M, Hannouche M, Kramer A, Seppelt I, Udy A, Kutsogiannis DJ, Zarychanski R, D'Aragon F, Boyd JG, Salt G, Bellapart J, Wood G, Cava L, Pickett G, Koffman L, Watpool I, Bass F, Hammond N, Ramsay T, Mallick R, Scales DC, Andersen CR, Fitzgerald E, Talbot P, Dowlatshahi D, Sinclair J, Acker J, Marshall SC, McIntyre L; SAHARA Trial Investigators on behalf of the Canadian Critical Care Trials Group; Canadian Critical Care Trials Group. Liberal or Restrictive Transfusion Strategy in Aneurysmal Subarachnoid Hemorrhage. N Engl J Med. 2025 Mar 13;392(11):1079-1088. doi: 10.1056/NEJMoa2410962. Epub 2024 Dec 9.
- Derived from this study: PubMed 34932836Carson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shane English, MD MSc FRCPC principal investigator
Ottawa Hospital Research Institute
23 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liberal RBC Transfusion Strategy and Restrictive RBC Transfusion Strategy in people with Subarachnoid Hemorrhage, Aneurysmal, run by Ottawa Hospital Research Institute at 23 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Canada, Australia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (mRS) (time frame: 12 months post). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03309579, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.