Subarachnoid HemorrhagePhase 2/3SAHaRA PilotNCT02483351
Aneurysmal Subarachnoid Hemorrhage: Red Blood Cell Transfusion and Outcome
A Phase 2/3 study testing Liberal Red Blood Cell Transfusion Strategy and Restrictive Red Blood Cell Transfusion Strategy in people with Subarachnoid Hemorrhage, run by Ottawa Hospital Research Institute at 3 sites in Canada.
Trial summary
The purpose of this study is to determine the feasibility of conducting a large trial examining the effect on clinical outcome of a liberal red blood cell (RBC) transfusion strategy compared to a restrictive strategy (usual care) in patients with aneurysmal subarachnoid hemorrhage (SAH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage
- What is being tested?
- Liberal Red Blood Cell Transfusion Strategy and Restrictive Red Blood Cell Transfusion Strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesCanada
- Study dates
- Oct 2015to Jan 2018
- Phase
- Phase 2/3
- 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 presentation
- First ever episode aneurysmal SAH
- Confirmed aneurysmal SAH diagnosis: as confirmed by treating Neurosurgeon or Neuro-interventionalist and supported by blood in subarachnoid space (demonstrated on cranial imaging or cerebrospinal fluid positive for xanthochromia) that is the result of a ruptured saccular aneurysm (confirmed by cranial imaging - cranial topography or magnetic resonance imaging angiography or catheter angiogram)
- Incident hemoglobin ≤100g/L within 14 days following SAH (defined by first day of hospital presentation)
Who cannot join
- Physician and or family decision to withdraw/withhold critical care at time of enrolment
- Active bleeding with hemodynamic instability at time of enrolment
- Patients with contra-indication or known objection to blood transfusions
- SAH due to causes other than saccular aneurysm rupture including mycotic, traumatic and dissecting aneurysms, and aneurysms associated with arteriovenous malformations.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Hamilton Health Sciences Centre
Hamilton, Ontario
Shane English
Ottawa, Ontario, K1Y 4E9
Vancouver General Hospital
Vancouver, British Columbia
About this study
Official title: Aneurysmal Subarachnoid Hemorrhage: Red Blood Cell Transfusion and Outcome - A Pilot Randomized Controlled Trial
The purpose of this study is to determine the feasibility of conducting a large trial examining the effect on clinical outcome of a liberal red blood cell (RBC) transfusion strategy compared to a restrictive strategy (usual care) in patients with aneurysmal subarachnoid hemorrhage (SAH).
- Conditions
- Subarachnoid Hemorrhage
- Being tested
- Liberal Red Blood Cell Transfusion Strategy, Restrictive Red Blood Cell Transfusion Strategy
- Keywords
- Blood Transfusion
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liberal Red Blood Cell Transfusion StrategyOther
RBC Transfusion strategy with hemoglobin trigger of 100g/L
Restrictive Red Blood Cell Transfusion StrategyOther
Optional RBC Transfusion with hemoglobin trigger of <=80g/L
| Study group | Role | What they receive |
|---|---|---|
| Liberal RBC Transfusion Strategy | Experimental | Not described Receives: Other: Liberal Red Blood Cell Transfusion Strategy |
| Restrictive RBC Transfusion Strategy | Active comparator | Not described Receives: Other: Restrictive Red Blood Cell Transfusion Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Randomization Rate
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startOct 2015
- Primary completionJan 2018
- Study completionJan 2018
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 HemorrhageStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shane English, Ottawa Hospital Research Institute
- Investigators
- Shane English, MD MSc FRCPC, Principal investigator, Ottawa Hospital Research InstituteLauralyn McIntyre, MD MSc FRCPC, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483351
- Sponsor's protocol ID
- 20150433-01H
- Acronym
- SAHaRA Pilot
- Status last verified
- Apr 2018
- First submitted
- 25 Jun 2015
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
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 41114449Carson 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 34932836English SW, Fergusson D, Chasse M, Turgeon AF, Lauzier F, Griesdale D, Algird A, Kramer A, Tinmouth A, Lum C, Sinclair J, Marshall S, Dowlatshahi D, Boutin A, Pagliarello G, McIntyre LA; Canadian Critical Care Trials Group. Aneurysmal SubArachnoid Hemorrhage-Red Blood Cell Transfusion And Outcome (SAHaRA): a pilot randomised controlled trial protocol. BMJ Open. 2016 Dec 7;6(12):e012623. doi: 10.1136/bmjopen-2016-012623.
PubMed 27927658
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aneurysmal Subarachnoid Hemorrhage: Red Blood Cell Transfusion and Outcome - A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02483351
- Acronym / sponsor ID
- SAHaRA Pilot / 20150433-01H
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- Blood Transfusion
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 26 Jun 2015 (estimated)
- 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 purpose of this study is to determine the feasibility of conducting a large trial examining the effect on clinical outcome of a liberal red blood cell (RBC) transfusion strategy compared to a restrictive strategy (usual care) in patients with aneurysmal subarachnoid hemorrhage (SAH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberal RBC Transfusion Strategy | Experimental | Other: Liberal Red Blood Cell Transfusion Strategy |
| Restrictive RBC Transfusion Strategy | Active comparator | Other: Restrictive Red Blood Cell Transfusion Strategy |
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 presentation
- First ever episode aneurysmal SAH
- Confirmed aneurysmal SAH diagnosis: as confirmed by treating Neurosurgeon or Neuro-interventionalist and supported by blood in subarachnoid space (demonstrated on cranial imaging or cerebrospinal fluid positive for xanthochromia) that is the result of a ruptured saccular aneurysm (confirmed by cranial imaging - cranial topography or magnetic resonance imaging angiography or catheter angiogram)
- Incident hemoglobin ≤100g/L within 14 days following SAH (defined by first day of hospital presentation)
Key exclusion criteria (4 listed)
- Physician and or family decision to withdraw/withhold critical care at time of enrolment
- Active bleeding with hemodynamic instability at time of enrolment
- Patients with contra-indication or known objection to blood transfusions
- SAH due to causes other than saccular aneurysm rupture including mycotic, traumatic and dissecting aneurysms, and aneurysms associated with arteriovenous 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 Red Blood Cell Transfusion StrategyRBC Transfusion strategy with hemoglobin trigger of 100g/L | Other | Liberal RBC Transfusion Strategy |
| Restrictive Red Blood Cell Transfusion StrategyOptional RBC Transfusion with hemoglobin trigger of <=80g/L | Other | Restrictive RBC Transfusion Strategy |
Primary outcome
Randomization Rate
Time frame: 12 months
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 4 Apr 2018.
- 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 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.
- Derived from this study: PubMed 27927658English SW, Fergusson D, Chasse M, Turgeon AF, Lauzier F, Griesdale D, Algird A, Kramer A, Tinmouth A, Lum C, Sinclair J, Marshall S, Dowlatshahi D, Boutin A, Pagliarello G, McIntyre LA; Canadian Critical Care Trials Group. Aneurysmal SubArachnoid Hemorrhage-Red Blood Cell Transfusion And Outcome (SAHaRA): a pilot randomised controlled trial protocol. BMJ Open. 2016 Dec 7;6(12):e012623. doi: 10.1136/bmjopen-2016-012623.
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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
Lauralyn McIntyre, MD MSc FRCPC principal investigator
Ottawa Hospital Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Liberal Red Blood Cell Transfusion Strategy and Restrictive Red Blood Cell Transfusion Strategy in people with Subarachnoid Hemorrhage, run by Ottawa Hospital Research Institute at 3 sites in Canada.
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 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Randomization Rate (time frame: 12 months). 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 NCT02483351, 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 4 Apr 2018.