Tranexamic Acid for Preventing Progressive Intracranial Haemorrhage in Traumatic Brain Injury
Recruitment status was Recruiting
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Tranexamic Acid for Preventing Progressive Intracranial Haemorrhage in Adults With Traumatic Brain Injury; a Randomised, Double-blinded, Placebo-controlled Trial |
- Progressive intracranial haemorrhage at 24 ± 8 hours confirmed by repeated CT Brain [ Time Frame: 24 ± 8 hours ] [ Designated as safety issue: Yes ]
- 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: | October 2009 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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
Other Name: Transamin
|
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 |
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| Contact: Surakrant - Yutthakasemsunt, M.D | +66-4333-6144 ext - | surakrant@gmail.com |
| Thailand | |
| 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 | |
| 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
No publications provided
| Responsible Party: | Surakrant Yutthakasemsunt, Khon Kaen University |
| ClinicalTrials.gov Identifier: | NCT00755209 History of Changes |
| Other Study ID Numbers: | HE 510606 |
| Study First Received: | September 16, 2008 |
| Last Updated: | August 12, 2009 |
| 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 |
Additional relevant MeSH terms:
|
Hemorrhage Intracranial Hemorrhages Brain Injuries Intracranial Hemorrhage, Traumatic Pathologic Processes Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Craniocerebral Trauma |
Trauma, Nervous System Wounds and Injuries Antifibrinolytic Agents Tranexamic Acid Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hemostatics Coagulants Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013