Traumatic Brain Injury
Conditions
Keywords
Traumatic Brain Injury, Blood Transfusion
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
Interventions
BEHAVIORALLiberal transfusion strategy
Patients will have red blood cells transfused only if Hb \< 9.0 g/dL
BEHAVIORALRestrictive transfusion strategy
Patients will have red blood cells transfused only if Hb \< 7.0 g/dL
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin difference | 14 days | Hemoglobin difference between restrictive and liberal groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 | — |
| ICU mortality | 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 |
| Re-bleeding | 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 |
| Hospital length of stay | 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 | — |
| Mechanical ventilation free days | 28 days | Days breathing without assistance from hospital admission to day 28. |
| Extended Glasgow Outcome Scale at hospital discharge | 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 | — |
| Acute Respiratory Distress Syndrome | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | — |
| Septic Shock | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | — |
| 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 |
Countries
Brazil
Outcome results
None listed