Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 to 65

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

PhasePhase 3
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment80 (estimated)
SponsorAssiut University
Academic / other
Locations1 site (Asyut)
StatusRecruiting
StartedJune 5, 2021
Main results expectedJanuary 10, 2027
Study endsJanuary 30, 2027
Registry record updatedAugust 5, 2025
Trial IDNCT04910464 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.