Transfusion Requirements After Head Trauma

Study Overview
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Brief Summary
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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

Official Title
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Transfusion Requirements After Head Trauma

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Behavioral: Liberal transfusion strategy
* Behavioral: Restrictive transfusion strategy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liberal<br>Liberal transfusion strategy. Patients will have red blood cells transfused only if Hb < 9.0 g/dL | Behavioral: Liberal transfusion strategy<br>* Patients will have red blood cells transfused only if Hb < 9.0 g/dL<br>|
| Experimental: Restrictive<br>Restrictive transfusion strategy. Patients will have red blood cells transfused only if Hb < 7.0 g/dL | Behavioral: Restrictive transfusion strategy<br>* Patients will have red blood cells transfused only if Hb < 7.0 g/dL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin difference | Hemoglobin difference between restrictive and liberal groups | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Positive blood culture with a pathogenic microorganism | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | 
| Re-bleeding |  | 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 | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | 
| 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 | Days breathing without assistance from hospital admission to day 28. | 28 days | 
| 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 | 
| Cerebral autoregulation | Cerebral autoregulation as measure by the transcranial doppler | 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 | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic Brain Injury, Blood Transfusion