NCT04910464 Early Tranexamic Acid and Modulating the Inflammatory Response in Sepsis
| NCT ID | NCT04910464 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Assiut University |
| Condition | Sepsis |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2021-06-05 |
| Primary Completion | 2027-01-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 80 participants in total. It began in 2021-06-05 with a primary completion date of 2027-01-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In this study, our aim is to investigate the role tranexamic acid in modulating inflammation in patients with sepsis.
Eligibility 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)
Contact & Investigator
Omar Soliman, MD
PRINCIPAL INVESTIGATOR
Omar makram
Frequently Asked Questions
Who can join the NCT04910464 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04910464 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 80 participants.
Is NCT04910464 currently recruiting?
Yes, NCT04910464 is actively recruiting participants. Contact the research team at omarmakram347@yahoo.com for enrollment information.
Where is the NCT04910464 trial being conducted?
This trial is being conducted at Asyut, Egypt.
Who is sponsoring the NCT04910464 clinical trial?
NCT04910464 is sponsored by Assiut University. The principal investigator is Omar Soliman, MD at Omar makram. The trial plans to enroll 80 participants.