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Nebulized vs Intravenous Tranexamic Acid in Endoscopic Sinus Surgeries
NCT06777966Phase 4
Key facts
- Status
- Completed
- Start
- Jan 2025
- Primary completion
- Jul 2025
- Countries
- 1
- Sponsor
- Cairo University
- Modality
- Small Molecules
- Drugs
- tranexamic acid
- Conditions
- intraoperative bleeding
01
Overview
Phase 4, randomised, double-blind trial of tranexamic acid in intraoperative bleeding (2 arms), sponsored by Cairo University. Primary endpoint: Mean Wormald intraoperative surgical field grading at 5 hours. Started Jan 2025; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Nebulized group
Preoperative nebulizer session of 500 mg tranexamic acid + IV drip of 100 ml 0.9% normal saline.
Intravenous group
Preoperative IV drip of TXA 15 mg/kg in 100 ml normal saline + 5 ml 0.9% normal saline nebulizer session.
03
Who it enrols
Adults aged 18-60 with ASA class I or II undergoing endoscopic sinus surgeries under general anesthesia, excluding those with uncontrolled hypertension, bleeding disorders, or recent use of NSAIDs or anticoagulants.
04
Endpoints
Primary
Mean Wormald intraoperative surgical field grading
Secondary
Total blood loss
Bleeding rate
Operation time
Postoperative complications
Postoperative nasal bleeding
Postoperative intervention
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