Tranexamic Acid for Preventing Progressive Intracranial Haemorrhage in Traumatic Brain Injury

Brain Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00755209
• Other study ID #: HE 510606
• Status: Completed
• Phase: Phase 3
• First received: September 16, 2008
• Last updated: November 20, 2013
• Start date: October 2008
• Est. completion date: October 2009

Study information

• Verified date: November 2013
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Interventional

Clinical Trial Summary

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?"

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Hemorrhage
• Intracranial Hemorrhages

Intervention

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

Locations

Country	Name	City	State
Thailand	Khon Kaen Regional hospital	Muang district	Khon Kaen

Sponsors (3)

Lead Sponsor	Collaborator
Khon Kaen University	Khon Kaen Hospital, Thailand Research Fund

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progressive intracranial haemorrhage at 24 ± 8 hours confirmed by repeated CT Brain		24 ± 8 hours	Yes
Secondary	Functional scale (GOS), mortality, operative treatment (later surgery for bleeding), adverse effect and transfusion need		at discharge period	Yes