Tranexamic Acid for Preventing Progressive Intracranial Haemorrhage in Traumatic Brain Injury - Full Text View

Sponsors and Collaborators:	Khon Kaen University The Thai Research Fund Khon Kaen Regional Hospital
Information provided by:	Khon Kaen University
ClinicalTrials.gov Identifier:	NCT00755209

Purpose

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?"

Condition	Intervention	Phase
Brain Injuries	Drug: tranexamic acid	Phase III

MedlinePlus related topics: Traumatic Brain Injury

Drug Information available for: Tranexamic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Tranexamic Acid for Preventing Progressive Intracranial Haemorrhage in Adults With Traumatic Brain Injury; a Randomised, Double-Blinded, Placebo-Controlled Trial

Further study details as provided by Khon Kaen University:

Primary Outcome Measures:

Progressive intracranial haemorrhage at 24 ± 8 hours confirmed by repeated CT Brain [ Time Frame: 24 ± 8 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Functional scale (GOS, DRS), mortality, operative treatment (later surgery for bleeding), adverse effect and transfusion need [ Time Frame: at discharge period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	240
Study Start Date:	October 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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 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

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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755209

Contacts

Contact: Surakrant - Yutthakasemsunt, M.D

+66-4333-6144 ext -

surakrant@gmail.com

Locations

Thailand, Khon Kaen
Khon Kaen Regional hospital	Recruiting
Muang district, Khon Kaen, Thailand, 40000
Contact: Surakrant - Yutthakasemsunt, M.D +66-4333-6144 ext - surakrant@gmail.com
Contact: , M
Principal Investigator: Surakrant - Yutthakasemsunt, M.D

Sponsors and Collaborators

Khon Kaen University

The Thai Research Fund

Khon Kaen Regional Hospital

Investigators

Study Chair:	Surakrant - Yutthakasemsunt, M.D.	Faculty of Medicine; Khon Kaen University and Surgical unit; Khon Kaen Regional Hospital, Thailand
Principal Investigator:	Warawut - Kittiwattanagul, M.D.	Surgical Unit, Khon Kaen Regional Hospital, Thailand
Principal Investigator:	Parnumas - Piyavechvirat, M.D.	Surgical Unit, Khon Kaen Regional Hospital, Thailand
Principal Investigator:	Professor Pisake - Lumbiganon, M.D.,M.S.	Faculty of Medicine; Khon Kaen University, Thailand
Principal Investigator:	Asso. Professor Bandit - Thinkhamrop, M.P.H., Ph.D	Faculty of Public Health; Khon Kaen University, Thailand
Principal Investigator:	Professor Nakornchai - Phuenpathom, B.Sc., M.D.	Faculty of Medicine, Prince of Songkla University, Thailand
Principal Investigator:	Professor Ian G Roberts, MB,BCh,PhD.	Nutrition and Public Health Intervention Research Unit; London School of Hygiene & Tropical Medicine, U.K

More Information

Responsible Party:	Khon Kaen University ( Surakrant Yutthakasemsunt )
Study ID Numbers:	HE 510606
Study First Received:	September 16, 2008
Last Updated:	November 3, 2008
ClinicalTrials.gov Identifier:	NCT00755209
Health Authority:	Thailand: Khon Kaen University Ethics Committee for Human Research

Keywords provided by Khon Kaen University:

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

Study placed in the following topic categories:

Craniocerebral Trauma
Vascular Diseases
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin
Tranexamic Acid
Intracranial Hemorrhages

Trauma, Nervous System
Hemorrhage
Brain Diseases
Cerebrovascular Disorders
Antiplasmin
Brain Injuries

Additional relevant MeSH terms:

Fibrin Modulating Agents
Antifibrinolytic Agents
Pathologic Processes
Coagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Hematologic Agents
Nervous System Diseases
Cardiovascular Diseases
Hemostatics
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009