Tranexamic Acid for Preventing Progressive Intracranial Haemorrhage in Traumatic Brain Injury

Study Overview
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Brief Summary
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The study's objective is to evaluate the effectiveness and safety of tranexamic acid for adult patients with moderate to severe TBI.With the research question as Does TXA reduce the incidence of progressive intracranial haemorrhage by 50% compared to placebo in moderate to severe adult TBI patients at Khon Kaen Hospital?

Detailed Description
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Traumatic brain injury (TBI) is a major public health problem with poor outcome especially with progressive intracranial haemorrhage (PIH) in severe patients. There are links between coagulopathic change after brain injury and delayed traumatic haemorrhage revealed by CT brain. Antifibrinolytic treatment can reduce blood loss after surgery and perhaps in moderate to severe TBI by similar haemostatic responses. It is justified to determine benefit for reversing hyperfibrinolysis after TBI. Tranexamic acid (TXA) has been shown to have significant clinical benefit in effectively reducing surgical bleeding in systematic reviews. It has been shown to have no effect on coagulation parameters and no demonstrated harmful effect in systematic reviews. This study is designed to determine the effectiveness of TXA in preventing PIH in patients with moderate to severe TBI. The treatment regimen if effective can be applied in general trauma practice worldwide.

Official Title
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Tranexamic Acid for Preventing Progressive Intracranial Haemorrhage in Adults With Traumatic Brain Injury; a Randomised, Double-blinded, Placebo-controlled Trial

Conditions
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Brain Injuries

Intervention / Treatment
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* Drug: tranexamic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: moderate to severe injuries(post-resuscitation scores GCS 4-12) age >= 16 year non-penetrating TBI in 8 hours onset first CT brain in 8 hours onset non neurosurgical OR in 8 hours onset Exclusion Criteria: patients with coagulopathy serum creatinine over than 2 mg% with associated major organ injury requiring surgery within 8 hours of injury pregnancy receiving any medication which affects haemostasis

Ages Eligible for Study
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Minimum Age: 16 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Transamin<br>Drug: tranexamic acid Loading 1 gram ( 20 mg/kg) 100cc solution infuses in 30 minutes Maintenance 1 gram ( 2.5 mg/kg/hr) 1000cc solution infuses in 8 hours | Drug: tranexamic acid<br>* Loading 1 gram ( 20 mg/kg) 100cc solution infuses in 30 minutes Maintenance 1 gram ( 2.5 mg/kg/hr) 1000cc solution infuses in 8 hours<br>* Other names: Transamin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progressive intracranial haemorrhage at 24 ± 8 hours confirmed by repeated CT Brain |  | 24 ± 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional scale (GOS), mortality, operative treatment (later surgery for bleeding), adverse effect and transfusion need |  | at discharge period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic brain injury (TBI), Adults, Moderately severe TBI, Delayed traumatic intracranial haemorrhage, Expanding traumatic intracranial haemorrhage, Progressive intracranial haemorrhage (PIH), Antifibrinolytic agent, Tranexamic acid (TXA), Randomised, placebo-controlled trial, Human