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Recruiting Phase 3

Early Tranexamic Acid and Modulating the Inflammatory Response in Sepsis

NCT04910464 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 3
Started
2021-06-05
Last updated
2025-08-05

Condition(s) studied

Sepsis

Investigational drug(s) / intervention(s)

Tranexamic acid →0.9% saline

Tranexamic acid: administer 1 gram of TXA in 100 ml of 0.9% normal saline, intravenous over 10 minutes as soon as possible but no later than three hours after diagnosis, infuse a second gram of TXA IV over 8 hours in 0.9% normal saline for first 3 days.

0.9% saline: administer the same volume (100ml normal saline) and same duration (first three days).

Study summary

In this study, our aim is to investigate the role tranexamic acid in modulating inflammation in patients with sepsis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

  • ICU mortality — 7days
    Short-term ICU mortality within 7days of admission and intervention

Trial sites (1)

FacilityCityRegionStatus
Assiut university hospital Asyut Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04910464 on ClinicalTrials.gov ↗ ← All trials in Egypt