Transfusion Requirements After Head Trauma

Phase 2

Completed

• Conditions: Traumatic Brain Injury
• Interventions: Behavioral: Restrictive transfusion strategy; Behavioral: Liberal transfusion strategy

• Registration Number: NCT02203292
• Lead Sponsor: University of Sao Paulo

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-27
• Study First Submitted QC: 2014-07-27
• Study First Posted: 2014-07-29
• Study Start: 2014-08
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-28
• Last Update Posted: 2016-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restrictive	Restrictive transfusion strategy	Restrictive transfusion strategy. Patients will have red blood cells transfused only if Hb \< 7.0 g/dL
Liberal	Liberal transfusion strategy	Liberal transfusion strategy. Patients will have red blood cells transfused only if Hb \< 9.0 g/dL

Primary Outcome Measures

Name	Time	Method
Hemoglobin difference	14 days	Hemoglobin difference between restrictive and liberal groups

Secondary Outcome Measures

Name	Time	Method
Mechanical ventilation free days	28 days	Days breathing without assistance from hospital admission to day 28.
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
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
Blood stream infection	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	Positive blood culture with a pathogenic microorganism
Extended Glasgow Outcome Scale at hospital discharge	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Pulsatility index	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	Pulsatility index as measure by the transcranial doppler
Intensity of measures to reduce intracranial pressure	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	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Acute Respiratory Distress Syndrome	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
Re-bleeding	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
ICU length of stay	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Extended Glasgow Outcome Scale after 6 months	180 days
Myocardial Infarction	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Cerebral autoregulation	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	Cerebral autoregulation as measure by the transcranial doppler
Septic Shock	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Trial Locations

Locations (1)

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