Aneurysmal Subarachnoid Hemorrhage: Red Blood Cell Transfusion and Outcome

Subarachnoid Hemorrhage Clinical Trial

— SAHaRA Pilot  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02483351
• Other study ID #: 20150433-01H
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 25, 2015
• Last updated: April 3, 2018
• Start date: October 2015
• Est. completion date: January 2018

Study information

• Verified date: April 2018
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Other:
• Liberal Red Blood Cell Transfusion Strategy
RBC Transfusion strategy with hemoglobin trigger of 100g/L
• Restrictive Red Blood Cell Transfusion Strategy
Optional RBC Transfusion with hemoglobin trigger of <=80g/L

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences Centre	Hamilton	Ontario
Canada	Shane English	Ottawa	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Randomization Rate		12 months