We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified September 2017 by Alexis Turgeon, CHU de Quebec-Universite Laval
Sponsor:
ClinicalTrials.gov Identifier:
NCT03260478
First Posted: August 24, 2017
Last Update Posted: September 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Canadian Critical Care Trials Group
Canadian Traumatic Brain Injury Research Consortium
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Alexis Turgeon, CHU de Quebec-Universite Laval
  Purpose
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.

Condition Intervention
Traumatic Brain Injury Transfusion Procedure: Red Blood Cells Transfusion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Open-label with blinded outcome evaluation.
Primary Purpose: Treatment
Official Title: HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial

Resource links provided by NLM:


Further study details as provided by Alexis Turgeon, CHU de Quebec-Universite Laval:

Primary Outcome Measures:
  • extended Glasgow Outcome Scale (GOSe) [ Time Frame: 6 months ]
    Assessment of neurological outcome by the extended Glasgow Outcome Scale (GOSe)


Secondary Outcome Measures:
  • Mortality [ Time Frame: ICU, Hospital and at 6 months ]
    Assessment of patient mortality.

  • Functional Independence Measure (FIM) [ Time Frame: 6 months ]
    Assessment of patient function.

  • Quality of life (EQ-5D) [ Time Frame: 6 months ]
    Evaluation of the overall quality of life.

  • Quality of life (Qolibri questionnaires) [ Time Frame: 6 months ]
    Evaluation of the quality of life specific to the TBI.

  • Depression (PHQ-9) [ Time Frame: 6 months ]
    Assessment of depression.

  • Return to work/study of patient [ Time Frame: 6 months ]
    Assessment of patient's return to work/study or comparable previous activities.

  • Complications related to transfusion [ Time Frame: 6 months ]
    Assessment of complications related to RBC transfusions.


Estimated Enrollment: 712
Actual Study Start Date: September 1, 2017
Estimated Study Completion Date: December 1, 2021
Estimated Primary Completion Date: June 1, 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liberal Transfusion Strategy
Patients will receive red blood cells transfusion if Hb ≤ 100 g/L.
Procedure: Red Blood Cells Transfusion
Transfusion of packed red blood cells unit(s).
Experimental: Restrictive Transfusion Strategy
Patients will receive red blood cells transfusion if Hb ≤ 70 g/L.
Procedure: Red Blood Cells Transfusion
Transfusion of packed red blood cells unit(s).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260478


Contacts
Contact: Lucy Clayton, MSc 1 (514) 345-4931 ext 6816 Lucy.clayton@recherche-ste-justine.qc.ca
Contact: Alexis Turgeon, MD MSc FRCPC 1 (418) 649-0252 alexis.turgeon@fmed.ulaval.ca

Locations
Canada, Alberta
Foothills Medical Center Not yet recruiting
Calgary, Alberta, Canada
Royal Alexandra Hospital Not yet recruiting
Edmonton, Alberta, Canada
University of Alberta Hospital Not yet recruiting
Edmonton, Alberta, Canada
Canada, British Columbia
Vancouver General Hospital Not yet recruiting
Vancouver, British Columbia, Canada
Canada, Manitoba
Winnipeg Health Sciences Center Not yet recruiting
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre Not yet recruiting
Halifax, Nova Scotia, Canada
Canada, Ontario
Hamilton Health Sciences Center Not yet recruiting
Hamilton, Ontario, Canada
London Health Sciences Center Not yet recruiting
London, Ontario, Canada
The Ottawa Hospital Not yet recruiting
Ottawa, Ontario, Canada
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada
Sunnybrook Research Institute Not yet recruiting
Toronto, Ontario, Canada
Canada, Quebec
Hôpital Sacré-Coeur de Montréal Not yet recruiting
Montréal, Quebec, Canada
McGill University Health Center Not yet recruiting
Montréal, Quebec, Canada
CIUSSS De l'Estrie Not yet recruiting
Sherbrooke, Quebec, Canada
CIUSSS Mauricie-et-Centre-du-Québec Not yet recruiting
Trois-Rivières, Quebec, Canada
Canada
CHU de Québec-Université Laval (Hôpital de l'Enfant-Jésus), Université Laval Recruiting
Québec, Canada
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Canadian Critical Care Trials Group
Canadian Traumatic Brain Injury Research Consortium
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: 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
  More Information

Responsible Party: Alexis Turgeon, Associate Professor, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT03260478     History of Changes
Other Study ID Numbers: MP-20-2018-3706
First Submitted: August 22, 2017
First Posted: August 24, 2017
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alexis Turgeon, CHU de Quebec-Universite Laval:
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

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System