NCT02203292

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 1, 2016

Status Verified

July 1, 2016

Enrollment Period

1.8 years

First QC Date

July 27, 2014

Last Update Submit

July 28, 2016

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain InjuryBlood Transfusion

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin difference

    Hemoglobin difference between restrictive and liberal groups

    14 days

Secondary Outcomes (18)

  • Number of transfused patients

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

  • Number of red blood cell packages transfused

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

  • ICU mortality

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

  • Hospital mortality

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

  • 180 days mortality

    Participants will be followed for 180 after hospital discharge

  • +13 more secondary outcomes

Study Arms (2)

Liberal

ACTIVE COMPARATOR

Liberal transfusion strategy. Patients will have red blood cells transfused only if Hb \< 9.0 g/dL

Behavioral: Liberal transfusion strategy

Restrictive

EXPERIMENTAL

Restrictive transfusion strategy. Patients will have red blood cells transfused only if Hb \< 7.0 g/dL

Behavioral: Restrictive transfusion strategy

Interventions

Liberal transfusion strategyBEHAVIORAL

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

Liberal
Restrictive transfusion strategyBEHAVIORAL

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

Restrictive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

São Paulo, São Paulo, Brazil

Location

Related Publications (4)

  • 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.

    PMID: 41114449DERIVED

  • 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.

    PMID: 38961443DERIVED

  • 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.

    PMID: 34932836DERIVED

  • 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.

    PMID: 30871608DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • André LN Gobatto, M.D.

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

July 27, 2014

First Posted

July 29, 2014

Study Start

August 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 1, 2016

Record last verified: 2016-07

Locations

BR(1)