Back to resultsTransfusion Requirements After Head Trauma (TRAHT)
Primary Purpose
Traumatic Brain Injury
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Liberal transfusion strategy
Restrictive transfusion strategy
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Traumatic Brain Injury, Blood Transfusion
Eligibility 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
Sites / Locations
- Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Liberal
Restrictive
Arm Description
Liberal transfusion strategy. Patients will have red blood cells transfused only if Hb < 9.0 g/dL
Restrictive transfusion strategy. Patients will have red blood cells transfused only if Hb < 7.0 g/dL
Outcomes
Primary Outcome Measures
Hemoglobin difference
Hemoglobin difference between restrictive and liberal groups
Secondary Outcome Measures
Number of transfused patients
Number of red blood cell packages transfused
ICU mortality
Hospital mortality
180 days mortality
Blood stream infection
Positive blood culture with a pathogenic microorganism
Re-bleeding
Intensity of measures to reduce intracranial pressure
Measures to reduce intracranial pressure such as sedation, hypertonic solutions, hypothermia, liquorice drainage, decompressive craniectomy or hyperventilation
Hospital length of stay
ICU length of stay
Mechanical ventilation free days
Days breathing without assistance from hospital admission to day 28.
Extended Glasgow Outcome Scale at hospital discharge
Extended Glasgow Outcome Scale after 6 months
Myocardial Infarction
Acute Respiratory Distress Syndrome
Septic Shock
Cerebral autoregulation
Cerebral autoregulation as measure by the transcranial doppler
Pulsatility index
Pulsatility index as measure by the transcranial doppler
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02203292
Brief Title
Transfusion Requirements After Head Trauma
Acronym
TRAHT
Official Title
Transfusion Requirements After Head Trauma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Traumatic Brain Injury, Blood Transfusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liberal
Arm Type
Active Comparator
Arm Description
Liberal transfusion strategy. Patients will have red blood cells transfused only if Hb < 9.0 g/dL
Arm Title
Restrictive
Arm Type
Experimental
Arm Description
Restrictive transfusion strategy. Patients will have red blood cells transfused only if Hb < 7.0 g/dL
Intervention Type
Behavioral
Intervention Name(s)
Liberal transfusion strategy
Intervention Description
Patients will have red blood cells transfused only if Hb < 9.0 g/dL
Intervention Type
Behavioral
Intervention Name(s)
Restrictive transfusion strategy
Intervention Description
Patients will have red blood cells transfused only if Hb < 7.0 g/dL
Primary Outcome Measure Information:
Title
Hemoglobin difference
Description
Hemoglobin difference between restrictive and liberal groups
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Number of transfused patients
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Title
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
Title
ICU mortality
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Title
Hospital mortality
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Title
180 days mortality
Time Frame
Participants will be followed for 180 after hospital discharge
Title
Blood stream infection
Description
Positive blood culture with a pathogenic microorganism
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Title
Re-bleeding
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Title
Intensity of measures to reduce intracranial pressure
Description
Measures to reduce intracranial pressure such as sedation, hypertonic solutions, hypothermia, liquorice drainage, decompressive craniectomy or hyperventilation
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Title
Hospital length of stay
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Title
ICU length of stay
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Title
Mechanical ventilation free days
Description
Days breathing without assistance from hospital admission to day 28.
Time Frame
28 days
Title
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
Title
Extended Glasgow Outcome Scale after 6 months
Time Frame
180 days
Title
Myocardial Infarction
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Title
Acute Respiratory Distress Syndrome
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Title
Septic Shock
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Title
Cerebral autoregulation
Description
Cerebral autoregulation as measure by the transcranial doppler
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Title
Pulsatility index
Description
Pulsatility index as measure by the transcranial doppler
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
André LN Gobatto, M.D.
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
City
São Paulo
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
34932836
Citation
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.
Results Reference
derived
PubMed Identifier
30871608
Citation
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.
Results Reference
derived
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Transfusion Requirements After Head Trauma
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