Clinical trial NCT02203292: Transfusion Requirements After Head Trauma
Official title: Transfusion Requirements After Head Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Traumatic Brain Injury
Keywords: Traumatic Brain Injury
Blood Transfusion
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2014-07-29
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Hemoglobin difference
timeFrame: 14 days
Secondary outcomes:
measure: Number of transfused patients
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Number of red blood cell packages transfused
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: ICU mortality
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Hospital mortality
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: 180 days mortality
timeFrame: Participants will be followed for 180 after hospital discharge
measure: Blood stream infection
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Re-bleeding
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Intensity of measures to reduce intracranial pressure
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Hospital length of stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: ICU length of stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Mechanical ventilation free days
timeFrame: 28 days
measure: Extended Glasgow Outcome Scale at hospital discharge
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Extended Glasgow Outcome Scale after 6 months
timeFrame: 180 days
measure: Myocardial Infarction
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Acute Respiratory Distress Syndrome
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Septic Shock
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Cerebral autoregulation
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Pulsatility index
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
Study officials:
affiliation: University of Sao Paulo
name: André LN Gobatto, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.