Aneurysmal Subarachnoid Hemorrhage: Red Blood Cell Transfusion and Outcome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-01-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Subarachnoid Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Liberal RBC Transfusion Strategy

Group Type EXPERIMENTAL

Liberal Red Blood Cell Transfusion Strategy

Intervention Type OTHER

RBC Transfusion strategy with hemoglobin trigger of 100g/L

Restrictive RBC Transfusion Strategy

Group Type ACTIVE_COMPARATOR

Restrictive Red Blood Cell Transfusion Strategy

Intervention Type OTHER

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

Interventions

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Liberal Red Blood Cell Transfusion Strategy

RBC Transfusion strategy with hemoglobin trigger of 100g/L

Intervention Type OTHER

Restrictive Red Blood Cell Transfusion Strategy

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No