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

Traumatic Brain Injury Clinical Trial

— HEMOTION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03260478
• Other study ID #: MP-20-2018-3706
• Status: Completed
• Phase: N/A
• Start date: August 31, 2017
• Est. completion date: February 16, 2024

Study information

• Verified date: May 2024
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 742
• Est. completion date: February 16, 2024
• Est. primary completion date: October 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Transfusion
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Procedure:
• Red Blood Cells Transfusion
Transfusion of packed red blood cells unit(s).

Locations

Country	Name	City	State
Brazil	Santa Casa de Misericórdia de Barretos	Barretos	Sao Paulo
Brazil	The Hospital das Clinicas da Facudade de Medicina da USP	São Paulo
Canada	Foothills Medical Center	Calgary	Alberta
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	Hamilton Health Sciences Center	Hamilton	Ontario
Canada	Kingston General Hospital	Kingston	Ontario
Canada	London Health Sciences Center	London	Ontario
Canada	Centre Hospitalier de l'Université de Montréal	Montréal	Quebec
Canada	McGill University Health Center	Montréal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	CHU de Québec-Université Laval (Hôpital de l'Enfant-Jésus), Université Laval	Québec
Canada	Regina General Hospital	Regina	Saskatchewan
Canada	CIUSSS De l'Estrie	Sherbrooke	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Research Institute	Toronto	Ontario
Canada	CIUSSS Mauricie-et-Centre-du-Québec	Trois-Rivières	Quebec
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Winnipeg Health Sciences Center	Winnipeg	Manitoba
France	CHU de Besançon	Besançon	Bourgogne-Franche-Comté
France	CHU de Clermont-Ferrand	Clermont-Ferrand	Auvergne-Rhône-Alpes
France	CHU de Nîmes	Nîmes	Occitanie
France	Hôpital de Hautepierre	Strasbourg	Grand Est
United Kingdom	University Hospital of Wales	Cardiff
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	Aintree University Hospital	Liverpool
United Kingdom	Walton Centre	Liverpool
United Kingdom	St. Mary's Hospital (Imperial College Healthcare)	London
United Kingdom	James Cook University Hospital	Middlesbrough
United Kingdom	University of Nottingham Hospital	Nottingham
United Kingdom	Salford Royal Hospital	Salford
United Kingdom	Royal Stoke University Hospital	Stoke-on-Trent

Sponsors (5)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval	Canadian Critical Care Trials Group, Canadian Institutes of Health Research (CIHR), Canadian Perioperative Anesthesia Clinical Trials (PACT) Group, Canadian Traumatic Brain Injury Research Consortium

Countries where clinical trial is conducted

Brazil,  Canada,  France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number RBC transfusions	Assessment of the number of RBC transfusions.	While in the ICU, censored at 6 months after randomization
Other	Lowest Daily Hemoglobin	Assessment of the Median Lower Daily Hemoglobin.	While in the ICU, censored at 6 months after randomization
Other	Infections	Assessment of the incidence of infections.	While in the ICU, censored at 6 months after randomization
Other	Duration of mechanical ventilation	Duration of mechanical ventilation.	While in the ICU, censored at 6 months after randomization
Other	ICU Lenght of stay	Lenght of stay in the intensive care unit	While in the ICU, censored at 6 months after randomization
Other	Hospital Lenght of stay	Duration of hospitalization is study hospital	While in the hospital, censored at 6 months after randomization
Other	Complications related to transfusion	Assessment of complications related to RBC transfusions.	While in the ICU, censored at 6 months after randomization
Primary	extended Glasgow Outcome Scale (GOSe)	Assessment of neurological outcome by the extended Glasgow Outcome Scale (GOSe)	6 months
Secondary	Mortality	Assessment of patient mortality.	ICU, Hospital and at 6 months
Secondary	Functional Independence Measure (FIM)	Assessment of patient function.	6 months
Secondary	Quality of life (EQ-5D)	Evaluation of the overall quality of life.	6 months
Secondary	Quality of life (Qolibri questionnaires)	Evaluation of the quality of life specific to the TBI.	6 months
Secondary	Depression (PHQ-9)	Assessment of depression.	6 months

External Links

•   Hemotion Trial website