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| Name | Class |
|---|---|
| Thailand Research Fund | OTHER |
| Khon Kaen Hospital | OTHER_GOV |
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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?"
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transamin | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tranexamic acid | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progressive intracranial haemorrhage at 24 ± 8 hours confirmed by repeated CT Brain | 24 ± 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Functional scale (GOS), mortality, operative treatment (later surgery for bleeding), adverse effect and transfusion need | at discharge period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Surakrant - Yutthakasemsunt, M.D. | Faculty of Medicine; Khon Kaen University and Surgical unit; Khon Kaen Regional Hospital, Thailand | Study Chair |
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Khon Kaen Regional hospital | Muang District | Changwat Khon Kaen | 40000 | Thailand |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |