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Tranexamic Acid for Preventing Progressive Intracranial Haemorrhage in Traumatic Brain Injury

Primary Purpose

Brain Injuries

Status

Completed

Phase

Phase 3

Locations

Thailand

Study Type

Interventional

Intervention

tranexamic acid

About this trial

This is an interventional treatment trial for Brain Injuries focused on measuring 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

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Khon Kaen Regional hospital

Arms of the Study

Arm 1

Arm Type

Placebo Comparator

Arm Label

Transamin

Arm 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

Outcomes

Primary Outcome Measures

Progressive intracranial haemorrhage at 24 ± 8 hours confirmed by repeated CT Brain

Secondary Outcome Measures

Functional scale (GOS), mortality, operative treatment (later surgery for bleeding), adverse effect and transfusion need

Full Information

NCT ID

NCT00755209

First Posted

September 16, 2008

Last Updated

November 20, 2013

Sponsor

Khon Kaen University

Collaborators

Thailand Research Fund, Khon Kaen Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00755209

Brief Title

Tranexamic Acid for Preventing Progressive Intracranial Haemorrhage in Traumatic Brain Injury

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Khon Kaen University

Collaborators

Thailand Research Fund, Khon Kaen Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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?"

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Injuries

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

238 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Transamin

Arm Type

Placebo Comparator

Arm 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

Intervention Type

Drug

Intervention Name(s)

tranexamic acid

Other Intervention Name(s)

Transamin

Intervention Description

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

Primary Outcome Measure Information:

Title

Progressive intracranial haemorrhage at 24 ± 8 hours confirmed by repeated CT Brain

Time Frame

24 ± 8 hours

Secondary Outcome Measure Information:

Title

Functional scale (GOS), mortality, operative treatment (later surgery for bleeding), adverse effect and transfusion need

Time Frame

at discharge period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: