Aneurysmal Subarachnoid Hemorrhage: Red Blood Cell Transfusion and Outcome (SAHaRA Pilot)

Ottawa Hospital Research Institute

Status and phase: Completed; Phase 3; Phase 2

Conditions: Subarachnoid Hemorrhage

Treatments: Other: Restrictive Red Blood Cell Transfusion Strategy; Other: Liberal Red Blood Cell Transfusion Strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT02483351

20150433-01H

Details and patient eligibility

About

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).

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Liberal RBC Transfusion Strategy

Experimental group

Treatment:

Other: Liberal Red Blood Cell Transfusion Strategy

Restrictive RBC Transfusion Strategy

Active Comparator group

Treatment:

Other: Restrictive Red Blood Cell Transfusion Strategy