Using tranexamic acid to reduce inflammation in traumatic brain injury
Official title: The Impact of Early Use of Dexamethasone Traumatic Brain Injury Upon the Inflammatory Response and Outcome
Run by Assiut University · NCT05323149 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut, Assuit) |
| Status | Recruiting |
| Started | May 18, 2022 |
| Main results expected | September 10, 2027 |
| Study ends | October 15, 2027 |
| Registry record updated | September 16, 2026 |
| Trial ID | NCT05323149 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 * All diabetic patients * Renal failure patients * pregnancy * Patient refusal to participate
Where it's running
-
Assiut university hospital
Asyut, Assuit, Egypt Recruiting
Study contacts
- Study coordinator: Omar Soliman
- Email: omar@aun.edu.eg
- Phone: 01101266040
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.