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Completed

NCT Number: NCT03260478

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

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.

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Key information

Conditions

Traumatic Brain Injury Anemia Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Hematologic Diseases Hemic and Lymphatic Diseases Nervous System Diseases Transfusion Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Santa Casa de Misericórdia de Barretos, Barretos, São Paulo, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Red blood cells transfusion

Procedure

Transfusion of packed red blood cells unit(s).

Primary outcomes

  1. extended Glasgow Outcome Scale (GOSe)

    Time frame: 6 months

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

Secondary outcomes

  1. Mortality

    Time frame: ICU, Hospital and at 6 months

    Assessment of patient mortality.

  2. Functional Independence Measure (FIM)

    Time frame: 6 months

    Assessment of patient function.

  3. Quality of life (EQ-5D)

    Time frame: 6 months

    Evaluation of the overall quality of life.

  4. Quality of life (Qolibri questionnaires)

    Time frame: 6 months

    Evaluation of the quality of life specific to the TBI.

  5. Depression (PHQ-9)

    Time frame: 6 months

    Assessment of depression.

Other outcomes

  1. Number RBC transfusions

    Time frame: While in the ICU, censored at 6 months after randomization

    Assessment of the number of RBC transfusions.

  2. Lowest Daily Hemoglobin

    Time frame: While in the ICU, censored at 6 months after randomization

    Assessment of the Median Lower Daily Hemoglobin.

  3. Infections

    Time frame: While in the ICU, censored at 6 months after randomization

    Assessment of the incidence of infections.

  4. Duration of mechanical ventilation

    Time frame: While in the ICU, censored at 6 months after randomization

    Duration of mechanical ventilation.

  5. ICU Lenght of stay

    Time frame: While in the ICU, censored at 6 months after randomization

    Lenght of stay in the intensive care unit

  6. Hospital Lenght of stay

    Time frame: While in the hospital, censored at 6 months after randomization

    Duration of hospitalization is study hospital

  7. Complications related to transfusion

    Time frame: While in the ICU, censored at 6 months after randomization

    Assessment of complications related to RBC transfusions.

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Collaborators

  • Canadian Critical Care Trials Group
  • Canadian Institutes of Health Research (CIHR)
  • Canadian Perioperative Anesthesia Clinical Trials (PACT) Group
  • Canadian Traumatic Brain Injury Research Consortium

Registry information

Acronym: HEMOTION

Important dates

Study start
2017
Primary completion
2023
Study completion
2024
First posted
Aug 24, 2017
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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