Using nebulized tranexamic acid to reduce blood loss in sinus surgery
Assessment of Nebulized Tranexamic Acid in Functional Endoscopic Sinus Surgery Using Modena Bleeding Score. A Randomized Double Blinded Controlled Trial.
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 |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut) |
| Trial ID | NCT06725732 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with chronic renal failure, liver cirrhosis, bleeding disorders, or those on anticoagulant therapy may not benefit from this study.
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 performed: While there have been studies on tranexamic acid in various surgical settings, this specific application in FESS is relatively novel and untested.
Eligibility criteria
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 this trial is running
Asyut
- Main building, Assiut University Hospitals — Asyut, Egypt (Recruiting)
Study contacts
- Study coordinator: Asmaa Shabaan Zanaty, Doctor
- Email: asmaa10557@gmail.com
- Phone: +201029505921
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.