Using nebulized tranexamic acid to reduce bleeding during sinus surgery
Does Nebulized Tranexamic Acid Affect Operative Field in Sinus Surgery? A Double Blind Randomized Clinical Trial
PHASE3 · Assiut University · NCT04905901
This study is testing whether using a mist of tranexamic acid can help reduce bleeding during sinus surgery for adults aged 18 to 65.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Assiut University (other) |
| Locations | 1 site (Asyut, Assuit) |
| Trial ID | NCT04905901 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of nebulized tranexamic acid in reducing intraoperative bleeding during functional endoscopic sinus surgery (FESS). It involves adults aged 18-65 who are scheduled for elective surgery and have a normal coagulation profile. Participants will be randomly assigned to receive either a saline placebo or different doses of tranexamic acid through nebulization. The study aims to determine the optimal dosage and assess the overall experience for both surgeons and patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a normal coagulation profile scheduled for elective functional endoscopic sinus surgery.
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 improve surgical outcomes and patient experiences by reducing bleeding during sinus surgery.
How similar studies have performed: Previous studies have shown promising results with tranexamic acid in similar surgical contexts, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Either sexes (age 18-65 years) of ASA I-II who are listed for elective functional endoscopic sinus surgery (FESS) under general anesthesia * 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.
Where this trial is running
Asyut, Assuit
- Assuit — Asyut, Assuit, Egypt (RECRUITING)
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: Bleeding Nose