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

NCT ID: NCT03260478

Last Updated: 2024-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

742 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-31

Study Completion Date

2024-02-16

Brief Summary

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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

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Conditions

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Traumatic Brain Injury Transfusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Open-label with blinded outcome evaluation.

Study Groups

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Liberal Transfusion Strategy

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

Group Type EXPERIMENTAL

Red Blood Cells Transfusion

Intervention Type PROCEDURE

Transfusion of packed red blood cells unit(s).

Restrictive Transfusion Strategy

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

Group Type EXPERIMENTAL

Red Blood Cells Transfusion

Intervention Type PROCEDURE

Transfusion of packed red blood cells unit(s).

Interventions

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Red Blood Cells Transfusion

Transfusion of packed red blood cells unit(s).

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Critical Care Trials Group

OTHER

Sponsor Role collaborator

Canadian Traumatic Brain Injury Research Consortium

UNKNOWN

Sponsor Role collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Canadian Perioperative Anesthesia Clinical Trials (PACT) Group

UNKNOWN

Sponsor Role collaborator

CHU de Quebec-Universite Laval

OTHER

Sponsor Role lead

Responsible Party

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Dr Alexis Turgeon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexis Turgeon, MD MSc FRCPC

Role: PRINCIPAL_INVESTIGATOR

CHU de Quebec-Université Laval Research Center

François Lauzier, MD MSc FRCPC

Role: PRINCIPAL_INVESTIGATOR

CHU de Quebec-Université Laval Research Center

Dean Fergusson, PhD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

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Santa Casa de Misericórdia de Barretos

Barretos, São Paulo, Brazil

Site Status

The Hospital das Clinicas da Facudade de Medicina da USP

São Paulo, , Brazil

Site Status

Foothills Medical Center

Calgary, Alberta, Canada

Site Status

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Site Status

University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status

Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

Winnipeg Health Sciences Center

Winnipeg, Manitoba, Canada

Site Status

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Site Status

Hamilton Health Sciences Center

Hamilton, Ontario, Canada

Site Status

Kingston General Hospital

Kingston, Ontario, Canada

Site Status

London Health Sciences Center

London, Ontario, Canada

Site Status

The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Sunnybrook Research Institute

Toronto, Ontario, Canada

Site Status

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Site Status

McGill University Health Center

Montreal, Quebec, Canada

Site Status

CIUSSS De l'Estrie

Sherbrooke, Quebec, Canada

Site Status

CIUSSS Mauricie-et-Centre-du-Québec

Trois-Rivières, Quebec, Canada

Site Status

Regina General Hospital

Regina, Saskatchewan, Canada

Site Status

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

Québec, , Canada

Site Status

CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne-Rhône-Alpes, France

Site Status

CHU de Besançon

Besançon, Bourgogne-Franche-Comté, France

Site Status

Hôpital de Hautepierre

Strasbourg, Grand Est, France

Site Status

CHU de Nîmes

Nîmes, Occitanie, France

Site Status

University Hospital of Wales

Cardiff, , United Kingdom

Site Status

Western General Hospital

Edinburgh, , United Kingdom

Site Status

Aintree University Hospital

Liverpool, , United Kingdom

Site Status

Walton Centre

Liverpool, , United Kingdom

Site Status

St. Mary's Hospital (Imperial College Healthcare)

London, , United Kingdom

Site Status

James Cook University Hospital

Middlesbrough, , United Kingdom

Site Status

University of Nottingham Hospital

Nottingham, , United Kingdom

Site Status

Salford Royal Hospital

Salford, , United Kingdom

Site Status

Royal Stoke University Hospital

Stoke-on-Trent, , United Kingdom

Site Status

Countries

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Brazil Canada France United Kingdom

References

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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.

Reference Type DERIVED
PMID: 38869931 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36216432 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Study Documents

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Document Type: Study Protocol

View Document

Related Links

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https://www.ctrc-ccrt.ca

Canadian Traumatic Brain Injury Research Consortium website

Other Identifiers

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MP-20-2018-3706

Identifier Type: -

Identifier Source: org_study_id

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