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Traumatic Brain InjuryPhase 2TRAHTNCT02203292

Transfusion Requirements After Head Trauma

A Phase 2 study testing Liberal transfusion strategy and Restrictive transfusion strategy in people with Traumatic Brain Injury, run by University of Sao Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Traumatic Brain Injury
What is being tested?
Liberal transfusion strategy and Restrictive transfusion strategy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteBrazil
Study dates
Aug 2014to Jun 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

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

    São Paulo, São Paulo

Other trials in Brazil

About this study

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

Being tested
Liberal transfusion strategy, Restrictive transfusion strategy
Keywords
Traumatic Brain Injury, Blood Transfusion
Medical subject headings
Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liberal transfusion strategyBehavioural

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

  • Restrictive transfusion strategyBehavioural

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

Study groups in NCT02203292
Study groupRoleWhat they receive
LiberalActive comparatorLiberal transfusion strategy. Patients will have red blood cells transfused only if Hb < 9.0 g/dL
Receives: Behavioral: Liberal transfusion strategy
RestrictiveExperimentalRestrictive transfusion strategy. Patients will have red blood cells transfused only if Hb < 7.0 g/dL
Receives: Behavioral: Restrictive transfusion strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hemoglobin difference

    Hemoglobin difference between restrictive and liberal groups

    Measured: 14 days

Secondary outcomes (18)

  1. Number of transfused patients

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

  2. Number of red blood cell packages transfused

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

  3. ICU mortality

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

  4. Hospital mortality

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

  5. 180 days mortality

    Measured: Participants will be followed for 180 after hospital discharge

  6. Blood stream infection

    Positive blood culture with a pathogenic microorganism

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

  7. Re-bleeding

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

  8. Intensity of measures to reduce intracranial pressure

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

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

  9. Hospital length of stay

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

  10. ICU length of stay

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

  11. Mechanical ventilation free days

    Days breathing without assistance from hospital admission to day 28.

    Measured: 28 days

  12. Extended Glasgow Outcome Scale at hospital discharge

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

  13. Extended Glasgow Outcome Scale after 6 months

    Measured: 180 days

  14. Myocardial Infarction

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

  15. Acute Respiratory Distress Syndrome

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

  16. Septic Shock

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

  17. Cerebral autoregulation

    Cerebral autoregulation as measure by the transcranial doppler

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

  18. Pulsatility index

    Pulsatility index as measure by the transcranial doppler

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02203292
Sponsor's protocol ID
32520914.3.0000.0068
Acronym
TRAHT
Status last verified
Jul 2016
First submitted
27 Jul 2014
Last updated
1 Aug 2016
Results posted
No
Data monitoring committee
No

Publications

  • Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.

    PubMed 41114449

  • Gobatto ALN, Solla D, Brasil S, Taccone FS, Carlotti CG Jr, Malbouisson LMS, Paiva WS. Progressive hemorrhagic injury and ischemia after severe traumatic brain injury according to hemoglobin transfusion thresholds: a post-hoc analysis of the transfusion requirements after head trauma trial. Crit Care. 2024 Jul 3;28(1):218. doi: 10.1186/s13054-024-04981-5. No abstract available.

    PubMed 38961443

  • Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.

    PubMed 34932836

  • Gobatto ALN, Link MA, Solla DJ, Bassi E, Tierno PF, Paiva W, Taccone FS, Malbouisson LM. Transfusion requirements after head trauma: a randomized feasibility controlled trial. Crit Care. 2019 Mar 12;23(1):89. doi: 10.1186/s13054-018-2273-9.

    PubMed 30871608

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Liberal transfusion strategy and Restrictive transfusion strategy in people with Traumatic Brain Injury, run by University of Sao Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin difference (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02203292, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2016; AzTrials last refreshed its copy on 30 Oct 2026.

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