HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial

Not Applicable

Completed

• Conditions: Transfusion; Traumatic Brain Injury
• Interventions: Procedure: Red Blood Cells Transfusion

• Registration Number: NCT03260478
• Lead Sponsor: CHU de Quebec-Universite Laval

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-22
• Study First Submitted QC: 2017-08-22
• Study First Posted: 2017-08-24
• Study Start: 2017-08-31
• Primary Completion: 2023-10-26
• Study Completion: 2024-02-16
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 742

Inclusion Criteria

• Acute moderate to severe blunt TBI
• Glasgow Coma Score [GCS] ≤ 12
• Hb level ≤ 100 g/L

Exclusion Criteria

• Patient has received transfusion after ICU admission
• Contraindications or known objection to transfusions
• Glasgow Coma Scale (GCS) of 3 with dilated fixed pupils.
• Patient is brain dead
• Active life-threatening bleeding with hemorrhagic shock or requiring urgent surgical procedure
• A decision to withold or withdraw life-sustaining therapies was made
• No fixed address

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restrictive Transfusion Strategy	Red Blood Cells Transfusion	Patients will receive red blood cells transfusion if Hb ≤ 70 g/L.
Liberal Transfusion Strategy	Red Blood Cells Transfusion	Patients will receive red blood cells transfusion if Hb ≤ 100 g/L.

Primary Outcome Measures

Name	Time	Method
extended Glasgow Outcome Scale (GOSe)	6 months	Assessment of neurological outcome by the extended Glasgow Outcome Scale (GOSe)

Secondary Outcome Measures

Name	Time	Method
Quality of life (EQ-5D)	6 months	Evaluation of the overall quality of life.
Quality of life (Qolibri questionnaires)	6 months	Evaluation of the quality of life specific to the TBI.
Mortality	ICU, Hospital and at 6 months	Assessment of patient mortality.
Functional Independence Measure (FIM)	6 months	Assessment of patient function.
Depression (PHQ-9)	6 months	Assessment of depression.

Trial Locations

Locations (33)

Santa Casa de Misericórdia de Barretos; 🇧🇷 Barretos, Sao Paulo, Brazil

The Hospital das Clinicas da Facudade de Medicina da USP; 🇧🇷 São Paulo, Brazil

Foothills Medical Center; 🇨🇦 Calgary, Alberta, Canada

Royal Alexandra Hospital; 🇨🇦 Edmonton, Alberta, Canada

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Winnipeg Health Sciences Center; 🇨🇦 Winnipeg, Manitoba, Canada

Queen Elizabeth II Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada

Hamilton Health Sciences Center; 🇨🇦 Hamilton, Ontario, Canada

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada

Scroll for more (23 remaining)