Assessment of Nebulized Tranexamic Acid in Functional Endoscopic Sinus Surgery Using Modena Bleed… (NCT06725732) | Clinical Trial Compass
RecruitingEarly Phase 1
Assessment of Nebulized Tranexamic Acid in Functional Endoscopic Sinus Surgery Using Modena Bleeding Score
Egypt90 participantsStarted 2025-01-29
Plain-language summary
The aim of this study is to investigate the effect of preoperative administration of intravenous or nebulized tranexamic acid on surgical field, blood loss, anesthetic consumption and hemodynamics of patients undergoing FESS.
Primary outcome Modena Bleeding Score (MBS) assessing surgical field Secondary outcome
1. Patient hemodynamics.
2. Anesthetic consumption, Extra doses of fentanyl and propofol and sevoflurane\>2
3. Postoperative complications: including any adverse effects to TXA e.g.nausea, vomiting, any visual disturbances, fits, and any thrombotic manifestation.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Either sex
. age 18-65 years
. ASA I-II who are listed for elective functional endoscopic sinus surgery (FESS) under general anesthesia
. normal accepted coagulation profile and hematocrit value ≥30
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is an early Phase 1 trial, what do we actually know so far about the safety of inhaled tranexamic acid when it's delivered directly into the sinuses, and what risks might I be taking on that aren't yet fully understood?
2How is the Modena Bleeding Score used to judge whether this nebulized tranexamic acid is working during my sinus surgery, and what happens if the surgical field visibility isn't adequate during the procedure?
3Compared to standard methods surgeons already use to control bleeding during functional endoscopic sinus surgery, why might it be worth considering this experimental nebulized approach instead?
4What would my experience actually look like as a participant — for example, would the nebulized medication be given before, during, or after the surgery, and does being in the trial change anything about how my procedure is performed?
5Given that this trial is still in its earliest phase and is actively recruiting, is there a more established treatment path I should consider first, or does my specific situation make this trial worth discussing as an option?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.