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Aneurysmal Subarachnoid Hemorrhage: Red Blood Cell Transfusion and Outcome

Aneurysmal Subarachnoid Hemorrhage: Red Blood Cell Transfusion and Outcome - A Pilot Randomized Controlled Trial

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02483351
Acronym
SAHaRA Pilot
Enrollment
60
Registered
2015-06-26
Start date
2015-10-31
Completion date
2018-01-31
Last updated
2018-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subarachnoid Hemorrhage

Keywords

Blood Transfusion

Brief 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).

Interventions

OTHERLiberal Red Blood Cell Transfusion Strategy

RBC Transfusion strategy with hemoglobin trigger of 100g/L

OTHERRestrictive Red Blood Cell Transfusion Strategy

Optional RBC Transfusion with hemoglobin trigger of \<=80g/L

Sponsors

Ottawa Hospital Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age ≥18 years old at time of presentation 2. First ever episode aneurysmal SAH 3. 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) 4. Incident hemoglobin ≤100g/L within 14 days following SAH (defined by first day of hospital presentation)

Exclusion criteria

1. Physician and or family decision to withdraw/withhold critical care at time of enrolment 2. Active bleeding with hemodynamic instability at time of enrolment 3. Patients with contra-indication or known objection to blood transfusions 4. SAH due to causes other than saccular aneurysm rupture including mycotic, traumatic and dissecting aneurysms, and aneurysms associated with arteriovenous malformations.

Design outcomes

Primary

MeasureTime frame
Randomization Rate12 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026