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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

Tracking Information
First Submitted Date  ICMJE July 27, 2014
First Posted Date  ICMJE July 29, 2014
Last Update Posted Date August 1, 2016
Study Start Date  ICMJE August 2014
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2014)
Hemoglobin difference [ Time Frame: 14 days ]
Hemoglobin difference between restrictive and liberal groups
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2014)
  • 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, hypotermia, liquoric drainage, decompressive craniectomy or hyperventiation
  • 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 asssistance 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transfusion Requirements After Head Trauma
Official Title  ICMJE Transfusion Requirements After Head Trauma
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Traumatic Brain Injury
Intervention  ICMJE
  • Behavioral: Liberal transfusion strategy
    Patients will have red blood cells transfused only if Hb < 9.0 g/dL
  • Behavioral: Restrictive transfusion strategy
    Patients will have red blood cells transfused only if Hb < 7.0 g/dL
Study Arms  ICMJE
  • Active Comparator: Liberal
    Liberal transfusion strategy. Patients will have red blood cells transfused only if Hb < 9.0 g/dL
    Intervention: Behavioral: Liberal transfusion strategy
  • Experimental: Restrictive
    Restrictive transfusion strategy. Patients will have red blood cells transfused only if Hb < 7.0 g/dL
    Intervention: Behavioral: Restrictive transfusion strategy
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 27, 2014)
44
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02203292
Other Study ID Numbers  ICMJE 32520914.3.0000.0068
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party André Luiz Nunes Gobatto, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: André LN Gobatto, M.D. University of Sao Paulo
PRS Account University of Sao Paulo
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP