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

NCT03260478 | Completed DMC

• 1 other identifier: MP-20-2018-3706
• Study Type: interventional
• Target: 742
• Locations: 4 countries
• Sites: 33

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.

Conditions

Traumatic Brain Injury; Transfusion

Keywords

Traumatic Brain Injury (TBI); Red Blood Cells (RBC) Transfusion; Intensive Care Unit (ICU); Transfusion Threshold; Anemia; Oxygen Delivery; Neurocritical Care; Critical Care Neurology and Trauma

Outcome Measures

Primary Outcomes (1)

• extended Glasgow Outcome Scale (GOSe)

  Assessment of neurological outcome by the extended Glasgow Outcome Scale (GOSe)

  6 months

Secondary Outcomes (5)

• Mortality

  ICU, Hospital and at 6 months

• Functional Independence Measure (FIM)

  6 months

• Quality of life (EQ-5D)

  6 months

• Quality of life (Qolibri questionnaires)

  6 months

• Depression (PHQ-9)

  6 months

Other Outcomes (7)

• Number RBC transfusions

  While in the ICU, censored at 6 months after randomization

• Lowest Daily Hemoglobin

  While in the ICU, censored at 6 months after randomization

• Infections

  While in the ICU, censored at 6 months after randomization

Study Arms (2)

Liberal Transfusion Strategy

EXPERIMENTAL

Patients will receive red blood cells transfusion if Hb ≤ 100 g/L.

Procedure: Red Blood Cells Transfusion

Restrictive Transfusion Strategy

EXPERIMENTAL

Patients will receive red blood cells transfusion if Hb ≤ 70 g/L.

Procedure: Red Blood Cells Transfusion

Interventions

Red Blood Cells Transfusion PROCEDURE

Transfusion of packed red blood cells unit(s).

Liberal Transfusion Strategy; Restrictive Transfusion Strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• Canadian Critical Care Trials Group: collaborator
• Canadian Traumatic Brain Injury Research Consortium: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Canadian Perioperative Anesthesia Clinical Trials (PACT) Group: collaborator

Study Sites (33)

Santa Casa de Misericórdia de Barretos

Barretos, São Paulo, Brazil

Location

The Hospital das Clinicas da Facudade de Medicina da USP

São Paulo, Brazil

Location

Foothills Medical Center

Calgary, Alberta, Canada

Location

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

Winnipeg Health Sciences Center

Winnipeg, Manitoba, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Location

Hamilton Health Sciences Center

Hamilton, Ontario, Canada

Location

Kingston General Hospital

Kingston, Ontario, Canada

Location

London Health Sciences Center

London, Ontario, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Sunnybrook Research Institute

Toronto, Ontario, Canada

Location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Location

McGill University Health Center

Montreal, Quebec, Canada

Location

CIUSSS De l'Estrie

Sherbrooke, Quebec, Canada

Location

CIUSSS Mauricie-et-Centre-du-Québec

Trois-Rivières, Quebec, Canada

Location

Regina General Hospital

Regina, Saskatchewan, Canada

Location

CHU de Québec-Université Laval (Hôpital de l'Enfant-Jésus), Université Laval

Québec, Canada

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne-Rhône-Alpes, France

Location

CHU de Besançon

Besançon, Bourgogne-Franche-Comté, France

Location

Hôpital de Hautepierre

Strasbourg, Grand Est, France

Location

CHU de Nîmes

Nîmes, Occitanie, France

Location

University Hospital of Wales

Cardiff, United Kingdom

Location

Western General Hospital

Edinburgh, United Kingdom

Location

Aintree University Hospital

Liverpool, United Kingdom

Location

Walton Centre

Liverpool, United Kingdom

Location

St. Mary's Hospital (Imperial College Healthcare)

London, United Kingdom

Location

James Cook University Hospital

Middlesbrough, United Kingdom

Location

University of Nottingham Hospital

Nottingham, United Kingdom

Location

Salford Royal Hospital

Salford, United Kingdom

Location

Royal Stoke University Hospital

Stoke-on-Trent, United Kingdom

Location

Related Publications (2)

• Turgeon AF, Fergusson DA, Clayton L, Patton MP, Neveu X, Walsh TS, Docherty A, Malbouisson LM, Pili-Floury S, English SW, Zarychanski R, Moore L, Bonaventure PL, Laroche V, Verret M, Scales DC, Adhikari NKJ, Greenbaum J, Kramer A, Rey VG, Ball I, Khwaja K, Wise M, Harvey D, Lamontagne F, Chabanne R, Algird A, Krueper S, Pottecher J, Zeiler F, Rhodes J, Rigamonti A, Burns KEA, Marshall J, Griesdale DE, Sisconetto LS, Kutsogiannis DJ, Roger C, Green R, Boyd JG, Wright J, Charbonney E, Nair P, Astles T, Sy E, Hebert PC, Chasse M, Gomez A, Ramsay T, Taljaard M, Fox-Robichaud A, Tinmouth A, St-Onge M, Costerousse O, Lauzier F; HEMOTION Trial Investigators on behalf of the Canadian Critical Care Trials Group, the Canadian Perioperative Anesthesia Clinical Trials Group, and the Canadian Traumatic Brain Injury Research Consortium. Liberal or Restrictive Transfusion Strategy in Patients with Traumatic Brain Injury. N Engl J Med. 2024 Aug 22;391(8):722-735. doi: 10.1056/NEJMoa2404360. Epub 2024 Jun 13.

  PMID: 38869931 DERIVED

• Turgeon AF, Fergusson DA, Clayton L, Patton MP, Zarychanski R, English S, Docherty A, Walsh T, Griesdale D, Kramer AH, Scales D, Burns KEA, Boyd JG, Marshall JC, Kutsogiannis DJ, Ball I, Hebert PC, Lamontagne F, Costerousse O, St-Onge M, Lessard Bonaventure P, Moore L, Neveu X, Rigamonti A, Khwaja K, Green RS, Laroche V, Fox-Robichaud A, Lauzier F; HEMOTION Trial Team, the Canadian Critical Care Trials Group, the Canadian Perioperative Anesthesia Clinical Trials Group and the Canadian Traumatic Brain Injury Research Consortium. Haemoglobin transfusion threshold in traumatic brain injury optimisation (HEMOTION): a multicentre, randomised, clinical trial protocol. BMJ Open. 2022 Oct 10;12(10):e067117. doi: 10.1136/bmjopen-2022-067117.

  PMID: 36216432 DERIVED

Related Links

• Canadian Traumatic Brain Injury Research Consortium website

MeSH Terms

Conditions

Brain Injuries, Traumatic; Anemia; Wounds and Injuries

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Alexis Turgeon, MD MSc FRCPC

  CHU de Quebec-Université Laval Research Center

  PRINCIPAL INVESTIGATOR

• François Lauzier, MD MSc FRCPC

  CHU de Quebec-Université Laval Research Center

  PRINCIPAL INVESTIGATOR

• Dean Fergusson, PhD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Open-label with blinded outcome evaluation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 24, 2017
• Study Start: August 31, 2017
• Primary Completion: October 26, 2023
• Study Completion: February 16, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

FR (4); BR (2); GB (9); CA (18)