NCT02483351

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 26, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

April 4, 2018

Status Verified

April 1, 2018

Enrollment Period

2.3 years

First QC Date

June 25, 2015

Last Update Submit

April 3, 2018

Conditions

Subarachnoid Hemorrhage

Keywords

Blood Transfusion

Outcome Measures

Primary Outcomes (1)

  • Randomization Rate

    12 months

Study Arms (2)

Liberal RBC Transfusion Strategy

EXPERIMENTAL
Other: Liberal Red Blood Cell Transfusion Strategy

Restrictive RBC Transfusion Strategy

ACTIVE COMPARATOR
Other: Restrictive Red Blood Cell Transfusion Strategy

Interventions

Liberal Red Blood Cell Transfusion StrategyOTHER

RBC Transfusion strategy with hemoglobin trigger of 100g/L

Liberal RBC Transfusion Strategy
Restrictive Red Blood Cell Transfusion StrategyOTHER

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

Restrictive RBC Transfusion Strategy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

Hamilton Health Sciences Centre

Hamilton, Ontario, Canada

Location

Shane English

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related Publications (3)

  • Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.

    PMID: 41114449DERIVED

  • 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.

    PMID: 34932836DERIVED

  • 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.

    PMID: 27927658DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Shane English, MD MSc FRCPC

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

  • Lauralyn McIntyre, MD MSc FRCPC

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Scientist

Study Record Dates

First Submitted

June 25, 2015

First Posted

June 26, 2015

Study Start

October 1, 2015

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

April 4, 2018

Record last verified: 2018-04

Locations

CA(3)