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?"
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
238
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
Khon Kaen Regional hospital
Muang District, Changwat Khon Kaen, Thailand
Progressive intracranial haemorrhage at 24 ± 8 hours confirmed by repeated CT Brain
Time frame: 24 ± 8 hours
Functional scale (GOS), mortality, operative treatment (later surgery for bleeding), adverse effect and transfusion need
Time frame: at discharge period
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