Pre-hospital Administration of Tranexamic Acid for Moderate and Severe Traumatic Brain Injury

Study Overview
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Brief Summary
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This study is a prospective single-centre randomized trial to compare the effect of tranexamic acid versus placebo in the pre-hospital management of patients with moderate and severe traumatic brain injury.

Detailed Description
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Traumatic brain injury (TBI) remains a significant public health concern with poor outcome and one of the unmet needs in medical care. Tranexamic acid (TXA) has been shown to reduce blood loss after elective surgery and improve outcomes after traumatic injury due to bleeding without obvious adverse events. In the CRASH-2 Intracranial Bleeding Study, with the nested randomized trial design, the study showed that treatment with TXA within 8 hours of injury was associated with a reduction in haemorrhage growth [adjusted difference, -3.8 ml, 95% confidence interval (CI), -11.5 ml to 3.9 ml], fewer focal ischaemic lesions [adjusted odds ratio (OR) 0.54, 95% CI 0.20 to 1.46] and fewer death (adjusted OR 0.49, 95% CI 0.22 to 1.06) for patients with TBI (Glasgow coma score ≤ 14). The study also provided direction for future research of TXA in TBI, especially for the patients with moderate and severe TBI in whom an intracranial intracranial bleed (defined as the presence of parenchymal, subdural or epidural haemorrhage) is common. Furtherly, results of the CRASH-2 trial stressed the importance of early adminstration with TXA for trauma patients, with the evidence showing that treatment of TXA within 1 hour post injury could significantly reduce the risk of death, while the benefit did not exist when TXA was administered more than 3 hours after injury. If the use of TXA could be incorporated into the pre-hospital management of TBI, the outcome of traumatically injured patients would be improved in an early stage. Thus, our study sets out to employ a randomized controlled study design, with a sample of 400 patients, to evaluate the efficacy and safety of early use of TXA in the pre-hospital management for moderate and severe TBI.

Official Title
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Pre-hospital Administration of Tranexamic Acid for Adults With Moderate and Severe Traumatic Brain Injury: a Randomized, Double-blinded, Placebo-controlled Trial

Conditions
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Brain Injuries, Traumatic

Intervention / Treatment
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* Drug: Tranexamic Acid
* Other: Sodium chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: moderate to severe injuries(post-resuscitation scores Glasgow coma score of 4-12) age >= 18 year non-penetrating TBI in 2 hours onset Exclusion Criteria: patients with coagulopathy pregnancy receiving any medication which affects haemostasis no consenting form

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic acid<br>Focused intervention | Drug: Tranexamic Acid<br>* Tranexamic acid 1 gram in 100 ml saline, by intravenous drip over 10 minutes, once patient admitted to the trial on the spot of TBI<br>* Other names: Transamin;|
| Placebo Comparator: Sodium chloride<br>Placebo control | Other: Sodium chloride<br>* Sodium Chloride solution (0.9%) 1 ml (gram) in 100 ml saline, by intravenous drip over 10 minutes, once patient admitted to the trial on the spot of TBI<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow Outcome Scale (GOS) | The GOS is five-category scale used for assessing the neurologic outcome after brain injury as follows: 1, death; 2, vegetative state - unable to interact with the environment; 3, severe disability - unable to live independently but able to follow commands; 4, moderate disability - capable of living independently but unable to return to work or school; and 5, good recovery - able to return to work or school. In our statistical analyses, the outcome will be further dichotomized in unfavorable (GOS 1-3) vs favorable (GOS 4-5); the proportion of unfavorable outcome will be compared between groups. | 6 months post injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular occlusive events | Vascular occlusive events includes myocardial infarction, stroke, pulmonary embolism, clinical evidence of deep vein thrombosis. | 6 months post injury | 
| Death |  | 6 months post injury | 
| Length of intensive care unit stay |  | 6 months post injury | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic brain injury