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

No results posted yet for this study

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03260478 on ClinicalTrials.gov