Nebulized Tranexamic Acid in Sinus Surgery

NCT04905901 | Recruiting Phase 3

• 1 other identifier: 17300595
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The results of several recent studies on endoscopic sinus surgery through topical administration of tranexamic acid are encouraging in terms of the efficacy of tranexamic acid for intraoperative bleeding and other pathological conditions.The purpose of this study is to analyze the efficacy of nebulized tranexamic acid to improve the surgeon and patient experiences of sinus surgery and know the effective and safe dose of nebulized tranexamic acid.

Conditions

Bleeding Nose

Outcome Measures

Primary Outcomes (1)

• the Modena Bleeding Score (MBS) assessing surgical field

  1= No bleeding, 2=Bleeding easily controlled by suctioning, washing or packing without any significant modification or slowing of surgical procedure, 3=Bleeding slowing surgical procedure, 4=Most of the maneuvers dedicated to bleeding control and 5=Bleeding that prevents every surgical procedure except those dedicated to bleeding control

  After anesthesia induction to 60 minute

Secondary Outcomes (4)

• HR

  Intraoperative duration

• MBP

  Intraoperative duration

• Anesthetic consumption

  Anesthesia duration

• Postoperative complications

  After operation to 24 hour

Study Arms (3)

Tranexamic acid 500 mg

EXPERIMENTAL

Nebulized tranexamic acid 500 mg 15 minutes before operation

Drug: Tranexamic acid

Tranexamic acid 1gm

EXPERIMENTAL

Nebulized tranexamic acid 1 gm 15 minutes before operation

Drug: Tranexamic acid

Saline placebo

PLACEBO COMPARATOR

Normal saline nebulization 15 minutes before operation

Other: Saline placebo

Interventions

Tranexamic acid DRUG

Tranexamic acid nebulization 15 minutes before sinus surgery

Also known as: Cyclokapron

Tranexamic acid 1gm; Tranexamic acid 500 mg

Saline placebo OTHER

Normal saline placebo nebulization 15 minutes before sinus surgery

Saline placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit

Asyut, Assuit, Assuit universi, Egypt

RECRUITING

MeSH Terms

Conditions

Epistaxis

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Egypt Assuit university hospital

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 28, 2021
• Study Start: May 6, 2021
• Primary Completion: April 5, 2026
• Study Completion: April 10, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

EG (1)