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Completed

NCT Number: NCT02203292

Transfusion Requirements After Head Trauma

TRAHT is a pilot randomized clinical trial designed to evaluate safety and feasibility of two red blood cells transfusion thresholds in moderate or severe traumatic brain injured patients

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age equal to or greater than 18 years
  • Moderate or severe traumatic brain injury, defined as Glasgow coma scale less than or equal to 12 at hospital admission
  • Hemoglobin lower than 9.0 g/dL within 7 days from hospital admission

Exclusion criteria

  • Glasgow coma scale equal to 3 with dilated pupils bilaterally
  • Previous neurological sequelae
  • Pregnant women
  • Jehovah's Witnesses
  • Hemorrhagic shock at randomization
  • Moribund patients
  • Unable to provide consent

Treatment and study plan

Liberal transfusion strategy

Behavioral

Patients will have red blood cells transfused only if Hb < 9.0 g/dL

Restrictive transfusion strategy

Behavioral

Patients will have red blood cells transfused only if Hb < 7.0 g/dL

Primary outcomes

  1. Hemoglobin difference

    Time frame: 14 days

    Hemoglobin difference between restrictive and liberal groups

Secondary outcomes

  1. Number of transfused patients

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  2. Number of red blood cell packages transfused

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  3. ICU mortality

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  4. Hospital mortality

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  5. 180 days mortality

    Time frame: Participants will be followed for 180 after hospital discharge

  6. Blood stream infection

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

    Positive blood culture with a pathogenic microorganism

  7. Re-bleeding

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  8. Intensity of measures to reduce intracranial pressure

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

    Measures to reduce intracranial pressure such as sedation, hypertonic solutions, hypothermia, liquorice drainage, decompressive craniectomy or hyperventilation

  9. Hospital length of stay

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  10. ICU length of stay

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  11. Mechanical ventilation free days

    Time frame: 28 days

    Days breathing without assistance from hospital admission to day 28.

  12. Extended Glasgow Outcome Scale at hospital discharge

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  13. Extended Glasgow Outcome Scale after 6 months

    Time frame: 180 days

  14. Myocardial Infarction

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  15. Acute Respiratory Distress Syndrome

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  16. Septic Shock

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  17. Cerebral autoregulation

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

    Cerebral autoregulation as measure by the transcranial doppler

  18. Pulsatility index

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

    Pulsatility index as measure by the transcranial doppler

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Acronym: TRAHT

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 29, 2014
Registry last updated
Aug 1, 2016

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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