Using tranexamic acid to reduce inflammation in traumatic brain injury
The Impact of Early Use of Tranexamic Acid in Traumatic Brain Injury Upon the Inflammatory Response and Outcome
This study is testing if giving tranexamic acid to patients with traumatic brain injury can help reduce inflammation and improve their recovery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut, Assuit) |
| Trial ID | NCT05323149 on ClinicalTrials.gov |
What this trial studies
This double-blind phase 3 trial investigates the effects of tranexamic acid (TXA) on inflammation in patients with traumatic brain injury (TBI). Participants will be randomly assigned to receive either TXA or a saline placebo after initial resuscitation in the emergency room. The study will monitor various inflammatory markers and clinical outcomes, including the Glasgow Coma Scale and hemodynamic stability, over a period of 48 hours. The goal is to determine if TXA can effectively modulate the inflammatory response associated with TBI.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with isolated mild to moderate traumatic brain injuries and a Glasgow Coma Scale score greater than 8.
Not a fit: Patients who are in cardiac arrest, have coagulopathies, renal failure, are pregnant, or refuse to participate may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to improved outcomes for patients suffering from traumatic brain injuries by reducing inflammation.
How similar studies have performed: While the use of tranexamic acid has shown promise in other trauma settings, this specific application in TBI is still being explored and is considered novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Isolated traumatic brain injury patients (mild or moderate cases) * GCS \> 8 * non penetrating TBI in 8 hours onset * Age ≥ 18 years Exclusion Criteria: * Patient in cardiac arrest * Patients with coagulopathies * Renal failure patients * pregnancy * Patient refusal to participate
Where this trial is running
Asyut, Assuit
- Assiut university hospital — Asyut, Assuit, Egypt (Recruiting)
Study contacts
- Study coordinator: Omar Soliman
- Email: omar@aun.edu.eg
- Phone: 01101266040
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.