Using tranexamic acid to reduce inflammation in sepsis patients
Official title: Could Early Tranexamic Acid Safely Serve as an Anti-inflammatory Treatment for Patients With Sepsis? A Randomized Double Blind Controlled Trial
Run by Assiut University · NCT04910464 · Data updated 2026-11-12
This study is testing if tranexamic acid can help reduce inflammation in patients with sepsis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut) |
| Status | Recruiting |
| Started | June 5, 2021 |
| Main results expected | January 10, 2027 |
| Study ends | January 30, 2027 |
| Registry record updated | August 5, 2025 |
| Trial ID | NCT04910464 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-65 with a qSOFA score of 2 or higher who require ICU admission.
✕Probably not a fit
Patients with chronic renal failure, liver cirrhosis, or those on anticoagulant therapy 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 study investigates the effects of tranexamic acid on inflammation in patients diagnosed with sepsis. Participants will be randomly assigned to receive either tranexamic acid or a saline control, with treatment starting as soon as possible after diagnosis. The study aims to assess the impact of tranexamic acid on the inflammatory response over a period of three days. Informed consent will be obtained from patients or their relatives prior to participation.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients suffering from sepsis by effectively modulating their inflammatory response.
How similar studies have gone: While the use of tranexamic acid has been explored in various contexts, this specific application in sepsis is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (age 18-65 years) of American society of anesthesiologists (ASA) I-II who will be diagnosed with sepsis by qSOFA ≥2 * \& needed ICU admission. Exclusion Criteria: * Chronic renal failure * Liver cirrhosis * Bleeding disorders or current anticoagulant therapy * Pregnancy or breastfeeding * Impaired color vision * Severe vascular ischemia, history of venous thrombosis \& pulmonary embolism * Long term treatment with acetylsalicylic acid or non-steroidal anti-inflammatory drugs not discontinued before ICU admission * Allergy to tranexamic acid (TXA)
Where it's running
-
Assiut university hospital
Asyut, Egypt Recruiting
Study contacts
- Principal investigator: Omar Soliman, MD — Omar makram
- Study coordinator: Omar Soliman
- Email: omarmakram347@yahoo.com
- Phone: 01101266040
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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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.