Traumatic Brain Injury
Conditions
Brief summary
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.
Interventions
DRUGTranexamic Acid (TXA)
30 patients will be randomized to A arm and 30 patients to B arm
DRUGNormal saline
30 patients will be randomized this arm C
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Age Less than 18 years old 2. Clinical diagnose of trauma to the Head and GCS score less than or equal to 13 with associated intracranial haemorrhage on cranial CT scan 3. Time of admission within 3 hour of injury.
Exclusion criteria
1. Patient Known pregnancy. 2. patient had Cardiac arrest prior to randomization 3. GCS score of 3 with bilateral unresponsive pupils 4. Known bleeding/clotting disorders. 5. Known seizure disorders. 6. Known history of severe renal impairment 7. Unknown time of injury 8. Prior TXA for current injury 9. Known venous or arterial thrombosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The early traumatic brain injury-related death in the hospital | 24 hour and 48 hour after injury | 2\. Decreasing the rate of early head injury-related death (within 24 hour after injury) |
| The difference between treatment group in the Intracranial haemorrhage growth | 24 hour | We will measure intracranial hemorrhage progression at 24 hours in all subjects with intracranial hemorrhage on the initial clinical CT scan |
| The difference between the treatment groups in the incidence of mortality | 28 days | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 28 days | Decreasing incidence of seizures, complications and other adverse events |
| Need for neurosurgical management | 28 day | Evacuation of acute subdural hematoma,Evacuation of epidural hematoma and Evacuation of traumatic intracerebral hematoma (contusions) |
| Pediatric Glasgow Outcome Scale Extended (GOS-E) Peds) | 6 months | Improving the Pediatric Glasgow Outcome Scale Extended (GOS-E Peds) scores |
| Pediatric Quality of Life (PedsQL) | 6 months | Improving the Paediatric Quality of Life (PedsQL) . The PedsQL is a continuous score that ranges from 0-100. |
| Days in the intensive care unit | 28 day | Decreasing days in intensive care unit within 28 day of injury |
| Need for blood transfusion | 48 hour | 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. |
Countries
Egypt
Contacts
Primary ContactMohamed Shams, Professor
Outcome results
None listed