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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Patients will have red blood cells transfused only if Hb \< 9.0 g/dL
Patients will have red blood cells transfused only if Hb \< 7.0 g/dL
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
Hemoglobin difference
Hemoglobin difference between restrictive and liberal groups
Time frame: 14 days
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
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
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
Measures to reduce intracranial pressure such as sedation, hypertonic solutions, hypothermia, liquorice drainage, decompressive craniectomy or hyperventilation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
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
Days breathing without assistance from hospital admission to day 28.
Time frame: 28 days
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
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
Pulsatility index
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