Clinical trial NCT00755209: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
Collaborators: name: Thailand Research Fund
name: Khon Kaen Hospital
First posted: 2008-09-18
Enrollment: 238
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progressive intracranial haemorrhage at 24 ± 8 hours confirmed by repeated CT Brain
timeFrame: 24 ± 8 hours
Secondary outcomes:
measure: Functional scale (GOS), mortality, operative treatment (later surgery for bleeding), adverse effect and transfusion need
timeFrame: at discharge period
Other outcomes:
Locations:
city: Muang district
country: Thailand
facility: Khon Kaen Regional hospital
state: Khon Kaen
Study officials:
affiliation: Faculty of Medicine; Khon Kaen University and Surgical unit; Khon Kaen Regional Hospital, Thailand
name: Surakrant - Yutthakasemsunt, M.D.
role: STUDY_CHAIR
affiliation: Surgical Unit, Khon Kaen Regional Hospital, Thailand
name: Warawut - Kittiwattanagul, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Surgical Unit, Khon Kaen Regional Hospital, Thailand
name: Parnumas - Piyavechvirat, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine; Khon Kaen University, Thailand
name: Professor Pisake - Lumbiganon, M.D.,M.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Public Health; Khon Kaen University, Thailand
name: Asso. Professor Bandit - Thinkhamrop, M.P.H., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, Prince of Songkla University, Thailand
name: Professor Nakornchai - Phuenpathom, B.Sc., M.D.
role: PRINCIPAL_INVESTIGATOR
References: