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Evaluate the effect of tranexamic acid on mortality in pediatric patients with traumatic brain injury. This could potentially lead to improved treatment protocols and better outcomes for this vulnerable population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TXA dose A arm | Active Comparator | Subjects will receive a 15 mg/kg bolus of Tranexamic acid over 20 minutes followed by 2 mg/kg/hr. infusion over 8 hours. The maximum bolus dose is 1000 mg, the maximum rate of infusion is 50 mg/min, and the maximum total maintenance dose is 1000 mg |
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| TXA dose B arm | Active Comparator | Subjects will receive a 30 mg/kg bolus of Tranexamic acid over 20 minutes followed by 4 mg/kg/hr. infusion over 8 hours. The maximum bolus dose is 2000 mg, the maximum rate of infusion is 100 mg/min, and the maximum total maintenance dose is 2000 mg |
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| Placebo arm C | Placebo Comparator | Subjects in the placebo group will receive a bolus dose of normal saline over 20 minutes followed by a normal saline infusion over 8 hours (in the same weight-based volume as the other study arms) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid (TXA) | Drug | 30 patients will be randomized to A arm and 30 patients to B arm |
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| Measure | Description | Time Frame |
|---|---|---|
| The early traumatic brain injury-related death in the hospital | 2. Decreasing the rate of early head injury-related death (within 24 hour after injury) | 24 hour and 48 hour after injury |
| The difference between treatment group in the Intracranial haemorrhage growth | We will measure intracranial hemorrhage progression at 24 hours in all subjects with intracranial hemorrhage on the initial clinical CT scan | 24 hour |
| The difference between the treatment groups in the incidence of mortality | Decreasing the rate of head injury-related death in hospital within 28 days of injury all-cause and cause-specific mortality, disability, vascular occlusive events (myocardial infarction, stroke, deep vein thrombosis, and pulmonary embolism) | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Need for neurosurgical management | Evacuation of acute subdural hematoma,Evacuation of epidural hematoma and Evacuation of traumatic intracerebral hematoma (contusions) | 28 day |
| Days in the intensive care unit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Shams, Professor | Contact | 201556300563 | hamspharma@gmail.comms |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Azhar University Hospital in New Damietta | Recruiting | Damietta | Egypt |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Normal saline | Drug | 30 patients will be randomized this arm C |
|
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Decreasing days in intensive care unit within 28 day of injury
| 28 day |
| Need for blood transfusion | Decreasing the total amount of blood products transfused in the initial 48 hours following randomization. Blood product transfusion volume will be measured at 24 hours, 48 hours. This will include volume of packed red blood cells, plasma, platelets, and cryoprecipitate in mL/kg. | 48 hour |
| Adverse events | Decreasing incidence of seizures, complications and other adverse events | 28 days |
| Pediatric Quality of Life (PedsQL) | Improving the Paediatric Quality of Life (PedsQL) . The PedsQL is a continuous score that ranges from 0-100. | 6 months |
| Pediatric Glasgow Outcome Scale Extended (GOS-E) Peds) | Improving the Pediatric Glasgow Outcome Scale Extended (GOS-E Peds) scores | 6 months |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |