Traumatic Brain Injury Clinical Trial
— HEMOTIONOfficial title:
HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial
Verified date | May 2024 |
Source | CHU de Quebec-Universite Laval |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
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 |
Brazil, Canada, France, United Kingdom,
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 |
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