HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial
NCT03260478 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 742
Last updated 2024-05-03
Summary
Most trauma deaths are related to traumatic brain injury (TBI). Although the management of patients has improved, mortality remains unacceptably high, and half of survivors of moderate and severe TBI are left with major functional impairment. Current management guidelines are based on limited evidence and practice is highly variable. Most acutely ill patients with TBI will develop anemia, which may decrease oxygen delivery to a fragile brain. While clinical practice is moving towards transfusing at low hemoglobin (Hb) levels, experts have expressed concerns regarding restrictive strategies, which may adversely affect clinical outcomes in TBI. Our primary objective is to evaluate the effect of red blood cell (RBC) transfusion thresholds on neurological functional outcome. We hypothesize that a liberal transfusion strategy improves outcomes compared to a restrictive strategy.
Conditions
- Traumatic Brain Injury
- Transfusion
Interventions
- PROCEDURE
-
Red Blood Cells Transfusion
Transfusion of packed red blood cells unit(s).
Sponsors & Collaborators
-
Canadian Critical Care Trials Group
collaborator OTHER -
Canadian Traumatic Brain Injury Research Consortium
collaborator UNKNOWN -
Canadian Institutes of Health Research (CIHR)
collaborator OTHER_GOV -
Canadian Perioperative Anesthesia Clinical Trials (PACT) Group
collaborator UNKNOWN -
CHU de Quebec-Universite Laval
lead OTHER
Principal Investigators
-
Alexis Turgeon, MD MSc FRCPC · CHU de Quebec-Université Laval Research Center
-
François Lauzier, MD MSc FRCPC · CHU de Quebec-Université Laval Research Center
-
Dean Fergusson, PhD · Ottawa Hospital Research Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-08-31
- Primary Completion
- 2023-10-26
- Completion
- 2024-02-16
Countries
- Brazil
- Canada
- France
- United Kingdom
Study Locations
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