Transfusion Requirements After Head Trauma (TRAHT)

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ClinicalTrials.gov Identifier: NCT02203292

Recruitment Status : Completed

First Posted : July 29, 2014

Last Update Posted : August 1, 2016

Sponsor:

Information provided by (Responsible Party):

André Luiz Nunes Gobatto, University of Sao Paulo

Study Description

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

Condition or disease	Intervention/treatment	Phase
Traumatic Brain Injury	Behavioral: Liberal transfusion strategy Behavioral: Restrictive transfusion strategy	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	44 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Transfusion Requirements After Head Trauma
Study Start Date :	August 2014
Actual Primary Completion Date :	June 2016
Actual Study Completion Date :	June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Transfusion and Donation Head Injuries

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

Hemoglobin difference [ Time Frame: 14 days ]
Hemoglobin difference between restrictive and liberal groups

Secondary Outcome Measures :

Number of transfused patients [ Time Frame: 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 ]
ICU mortality [ Time Frame: 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 ]
180 days mortality [ Time Frame: 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
Re-bleeding [ Time Frame: 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
Hospital length of stay [ Time Frame: 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 ]
Mechanical ventilation free days [ Time Frame: 28 days ]
Days breathing without assistance from hospital admission to day 28.
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 ]
Extended Glasgow Outcome Scale after 6 months [ Time Frame: 180 days ]
Myocardial Infarction [ Time Frame: 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 ]
Septic Shock [ Time Frame: 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
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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203292

Locations

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

Sponsors and Collaborators

University of Sao Paulo

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	André Luiz Nunes Gobatto, M.D., University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT02203292
Other Study ID Numbers:	32520914.3.0000.0068
First Posted:	July 29, 2014 Key Record Dates
Last Update Posted:	August 1, 2016
Last Verified:	July 2016

Keywords provided by André Luiz Nunes Gobatto, University of Sao Paulo:


Traumatic Brain Injury Blood Transfusion

Additional relevant MeSH terms:

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

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