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

Primary Purpose

Subarachnoid Hemorrhage

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Liberal Red Blood Cell Transfusion Strategy
Restrictive Red Blood Cell Transfusion Strategy
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subarachnoid Hemorrhage focused on measuring Blood Transfusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Vancouver General Hospital
  • Hamilton Health Sciences Centre
  • Shane English

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Liberal RBC Transfusion Strategy

Restrictive RBC Transfusion Strategy

Arm Description

Outcomes

Primary Outcome Measures

Randomization Rate

Secondary Outcome Measures

Full Information

First Posted
June 25, 2015
Last Updated
April 3, 2018
Sponsor
Ottawa Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02483351
Brief Title
Aneurysmal Subarachnoid Hemorrhage: Red Blood Cell Transfusion and Outcome
Acronym
SAHaRA Pilot
Official Title
Aneurysmal Subarachnoid Hemorrhage: Red Blood Cell Transfusion and Outcome - A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ottawa Hospital Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage
Keywords
Blood Transfusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liberal RBC Transfusion Strategy
Arm Type
Experimental
Arm Title
Restrictive RBC Transfusion Strategy
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Liberal Red Blood Cell Transfusion Strategy
Intervention Description
RBC Transfusion strategy with hemoglobin trigger of 100g/L
Intervention Type
Other
Intervention Name(s)
Restrictive Red Blood Cell Transfusion Strategy
Intervention Description
Optional RBC Transfusion with hemoglobin trigger of <=80g/L
Primary Outcome Measure Information:
Title
Randomization Rate
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years old at time of presentation First ever episode aneurysmal SAH 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) Incident hemoglobin ≤100g/L within 14 days following SAH (defined by first day of hospital presentation) Exclusion Criteria: Physician and or family decision to withdraw/withhold critical care at time of enrolment Active bleeding with hemodynamic instability at time of enrolment Patients with contra-indication or known objection to blood transfusions SAH due to causes other than saccular aneurysm rupture including mycotic, traumatic and dissecting aneurysms, and aneurysms associated with arteriovenous malformations.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shane English, MD MSc FRCPC
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lauralyn McIntyre, MD MSc FRCPC
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Hamilton Health Sciences Centre
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Shane English
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
34932836
Citation
Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
Results Reference
derived
PubMed Identifier
27927658
Citation
English SW, Fergusson D, Chasse M, Turgeon AF, Lauzier F, Griesdale D, Algird A, Kramer A, Tinmouth A, Lum C, Sinclair J, Marshall S, Dowlatshahi D, Boutin A, Pagliarello G, McIntyre LA; Canadian Critical Care Trials Group. Aneurysmal SubArachnoid Hemorrhage-Red Blood Cell Transfusion And Outcome (SAHaRA): a pilot randomised controlled trial protocol. BMJ Open. 2016 Dec 7;6(12):e012623. doi: 10.1136/bmjopen-2016-012623.
Results Reference
derived

Learn more about this trial

Aneurysmal Subarachnoid Hemorrhage: Red Blood Cell Transfusion and Outcome

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