Tranexamic Acid for Preventing Progressive Intracranial Haemorrhage in Traumatic Brain Injury

Khon Kaen University

Status and phase: Completed; Phase 3

Conditions: Brain Injuries

Treatments: Drug: tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT00755209

HE 510606

Details and patient eligibility

About

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?"

Full description

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.

Enrollment: 238 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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238 participants in 1 patient group, including a placebo group

Transamin

Placebo Comparator group

Description:

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

Treatment:

Drug: tranexamic acid