Using tranexamic acid to reduce inflammation in sepsis patients
Could Early Tranexamic Acid Safely Serve as an Anti-inflammatory Treatment for Patients With Sepsis? A Randomized Double Blind Controlled Trial
PHASE3 · Assiut University · NCT04910464
This study is testing if tranexamic acid can help reduce inflammation in patients with sepsis.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Assiut University (other) |
| Locations | 1 site (Asyut) |
| Trial ID | NCT04910464 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a qSOFA score of 2 or higher who require ICU admission.
Not a fit: Patients with chronic renal failure, liver cirrhosis, or those on anticoagulant therapy may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Asyut
- 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
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.
Conditions: Sepsis