Effect of Tranexamic Acid on Outcomes in Pediatric Traumatic Brain Injury
Clinical Trial Evaluating the Effect of Tranexamic Acid on the Clinical Outcomes in Pediatric Patients With Traumatic Brain Injury
This study is testing if giving tranexamic acid to children with serious head injuries can help them survive and recover better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 1 Month to 18 Years |
| Sex | All |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Damietta) |
| Trial ID | NCT06330935 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the impact of tranexamic acid on mortality rates in pediatric patients suffering from traumatic brain injury. The study focuses on children under 18 years old who have a Glasgow Coma Scale score of 13 or less and show signs of intracranial hemorrhage. Participants will receive either tranexamic acid or normal saline within three hours of their injury to assess the potential benefits of the treatment. The goal is to improve clinical outcomes and establish better treatment protocols for this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients under 18 years old with a clinical diagnosis of head trauma and a GCS score of 13 or less.
Not a fit: Patients who are pregnant, have a history of severe renal impairment, or have experienced cardiac arrest prior to randomization will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and better clinical outcomes for children with traumatic brain injuries.
How similar studies have performed: While the use of tranexamic acid has shown promise in other trauma-related studies, this specific application in pediatric traumatic brain injury is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Damietta
- Al-Azhar University Hospital in New Damietta — Damietta, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed Shams, Professor
- Email: hamspharma@gmail.comms
- Phone: 201556300563
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.