Aneurysmal Subarachnoid Hemorrhage: Red Blood Cell Transfusion and Outcome

Phase 2

Completed

• Conditions: Subarachnoid Hemorrhage
• Interventions: Other: Liberal Red Blood Cell Transfusion Strategy; Other: Restrictive Red Blood Cell Transfusion Strategy

• Registration Number: NCT02483351
• Lead Sponsor: Ottawa Hospital Research Institute

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-25
• Study First Submitted QC: 2015-06-25
• Study First Posted: 2015-06-26
• Study Start: 2015-10
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liberal RBC Transfusion Strategy	Liberal Red Blood Cell Transfusion Strategy	-
Restrictive RBC Transfusion Strategy	Restrictive Red Blood Cell Transfusion Strategy	-

Primary Outcome Measures

Name	Time	Method
Randomization Rate	12 months

Trial Locations

Locations (3)

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Hamilton Health Sciences Centre; 🇨🇦 Hamilton, Ontario, Canada

Shane English; 🇨🇦 Ottawa, Ontario, Canada