Using nebulized tranexamic acid to reduce blood loss in sinus surgery
Official title: Assessment of Nebulized Tranexamic Acid in Functional Endoscopic Sinus Surgery Using Modena Bleeding Score. A Randomized Double Blinded Controlled Trial.
Run by Assiut University · NCT06725732 · Data updated 2026-11-12
This study tests if giving a medication called tranexamic acid before sinus surgery can help reduce bleeding and improve the surgery for patients.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut) |
| Status | Recruiting |
| Started | January 29, 2025 |
| Main results expected | December 1, 2025 |
| Study ends | January 1, 2026 |
| Registry record updated | January 29, 2025 |
| Trial ID | NCT06725732 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-65 with an ASA classification of I-II, scheduled for elective FESS and having a normal coagulation profile.
✕Probably not a fit
Patients with chronic renal failure, liver cirrhosis, bleeding disorders, 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 preoperative administration of tranexamic acid, either intravenously or nebulized, on patients undergoing functional endoscopic sinus surgery (FESS). The primary focus is to assess the Modena Bleeding Score to evaluate the surgical field and blood loss during the procedure. Secondary outcomes include monitoring patient hemodynamics, anesthetic consumption, and any postoperative complications related to tranexamic acid. The study aims to improve surgical visibility and reduce complications associated with excessive bleeding during FESS.
Why it matters
Potential benefit: If successful, this approach could significantly enhance surgical outcomes by minimizing blood loss and improving visualization during sinus surgery.
How similar studies have gone: While there have been studies on tranexamic acid in various surgical settings, this specific application in FESS is relatively novel and untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Either sex 2. age 18-65 years 3. ASA I-II who are listed for elective functional endoscopic sinus surgery (FESS) under general anesthesia 4. normal accepted coagulation profile and hematocrit value ≥30 Exclusion Criteria: * • chronic renal failure * liver cirrhosis * bleeding disorders * 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 surgery * hemoglobin (HB) concentration \<10 mg/dl \_allergy to TXA. * BMI \> 35 kg/ m2
Where it's running
-
Main building, Assiut University Hospitals
Asyut, Egypt Recruiting
Study contacts
- Study coordinator: Asmaa Shabaan Zanaty, Doctor
- Email: asmaa10557@gmail.com
- Phone: +201029505921
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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.