RecruitingPhase 1Phase 2NCT06330935
Evaluating the Effect of Tranexamic Acid on the Clinical Outcomes in Patients With Traumatic Brain Injury
Clinical Trial Evaluating the Effect of Tranexamic Acid on the Clinical Outcomes in Pediatric Patients With Traumatic Brain Injury
Sponsor
Mansoura University
Enrollment
90 participants
Start Date
Mar 25, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 1 MonthMax Age: 18 Years
Inclusion Criteria3
- Age Less than 18 years old
- Clinical diagnose of trauma to the Head and GCS score less than or equal to 13 with associated intracranial haemorrhage on cranial CT scan
- Time of admission within 3 hour of injury.
Exclusion Criteria9
- Patient Known pregnancy.
- patient had Cardiac arrest prior to randomization
- GCS score of 3 with bilateral unresponsive pupils
- Known bleeding/clotting disorders.
- Known seizure disorders.
- Known history of severe renal impairment
- Unknown time of injury
- Prior TXA for current injury
- Known venous or arterial thrombosis
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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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06330935
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