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Transfusion Requirements After Head Trauma (TRAHT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

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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


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




Primary Outcome Measures :
  1. Hemoglobin difference [ Time Frame: 14 days ]
    Hemoglobin difference between restrictive and liberal groups


Secondary Outcome Measures :
  1. Number of transfused patients [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
  2. 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 ]
  3. ICU mortality [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
  4. Hospital mortality [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
  5. 180 days mortality [ Time Frame: Participants will be followed for 180 after hospital discharge ]
  6. 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

  7. Re-bleeding [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
  8. 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

  9. Hospital length of stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
  10. ICU length of stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
  11. Mechanical ventilation free days [ Time Frame: 28 days ]
    Days breathing without assistance from hospital admission to day 28.

  12. 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 ]
  13. Extended Glasgow Outcome Scale after 6 months [ Time Frame: 180 days ]
  14. Myocardial Infarction [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
  15. Acute Respiratory Distress Syndrome [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
  16. Septic Shock [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
  17. 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

  18. 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



Information from the National Library of Medicine

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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

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