Transfusion Requirements After Head Trauma (TRAHT)

July 28, 2016 updated by: André Luiz Nunes Gobatto, University of Sao Paulo
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil
        • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Liberal
Liberal transfusion strategy. Patients will have red blood cells transfused only if Hb < 9.0 g/dL
Behavioral: Liberal transfusion strategy
Patients will have red blood cells transfused only if Hb < 9.0 g/dL
EXPERIMENTAL: Restrictive
Restrictive transfusion strategy. Patients will have red blood cells transfused only if Hb < 7.0 g/dL
Behavioral: Restrictive transfusion strategy
Patients will have red blood cells transfused only if Hb < 7.0 g/dL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin difference
Time Frame: 14 days
Hemoglobin difference between restrictive and liberal groups
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of transfused patients
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
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
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
ICU mortality
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Hospital mortality
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
180 days mortality
Time Frame: Participants will be followed for 180 after hospital discharge
Participants will be followed for 180 after hospital discharge
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
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Re-bleeding
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
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
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Hospital length of stay
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
ICU length of stay
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Mechanical ventilation free days
Time Frame: 28 days
Days breathing without assistance from hospital admission to day 28.
28 days
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
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Extended Glasgow Outcome Scale after 6 months
Time Frame: 180 days
180 days
Myocardial Infarction
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Acute Respiratory Distress Syndrome
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Septic Shock
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
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
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
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
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: André LN Gobatto, M.D., University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

July 27, 2014

First Submitted That Met QC Criteria

July 27, 2014

First Posted (ESTIMATE)

July 29, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

August 1, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 32520914.3.0000.0068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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