Nebulized Tranexamic Acid in Sinus Surgery

NCT ID: NCT04905901

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-06
• Study Completion Date: 2025-12-25

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.

Detailed Description

A written informed consent will be taken from the patients.The study involved adults of either sexes (age 18-65 years) of ASA I-II who will be listed for elective functional endoscopic sinus surgery (FESS) under general anesthesia, with normal accepted coagulation profile and hematocrit value ≥30 %. Excluded from the study patients with 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, a hemoglobin (HB) concentration <10 mg/dl or allergy to TXA.

Randomization: A random number sequence created by an internet website (http://www. random.org) will be used for patients' allocation. The random number sequence was retained in closed opaque envelopes released the day of the surgery by an independent physician not involved in the study. Patients will be assigned randomly to three groups (30 subjects each); saline placebo (Group S) and two different doses of preemptive nebulized tranexamic acid (Group T1) and (Group T2).To keep blinding, Group S will receive 2 sessions of nebulization each by 5 ml saline. Group T1 will receive one nebulization session 500 mg tranexamic acid (5 ml) and another one by 5 ml saline. Group T2 will receive 2 nebulization sessions each by 500 mg tranexamic acid (each by 5 ml)

Conditions

Bleeding Nose

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tranexamic acid 500 mg

Nebulized tranexamic acid 500 mg 15 minutes before operation

Group Type: EXPERIMENTAL

Tranexamic acid

Intervention Type: DRUG

Tranexamic acid nebulization 15 minutes before sinus surgery

Tranexamic acid 1gm

Nebulized tranexamic acid 1 gm 15 minutes before operation

Group Type: EXPERIMENTAL

Tranexamic acid

Intervention Type: DRUG

Tranexamic acid nebulization 15 minutes before sinus surgery

Saline placebo

Normal saline nebulization 15 minutes before operation

Group Type: PLACEBO_COMPARATOR

Saline placebo

Intervention Type: OTHER

Normal saline placebo nebulization 15 minutes before sinus surgery

Interventions

Tranexamic acid

Tranexamic acid nebulization 15 minutes before sinus surgery

Intervention Type: DRUG

Saline placebo

Normal saline placebo nebulization 15 minutes before sinus surgery

Intervention Type: OTHER

Other Intervention Names

Cyclokapron

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Omar Makram Soliman

Egypt Assuit university hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assuit

Asyut, Assuit, Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Omar Soliman

Role: primary

omarmakram347@yahoo.com

01101266040

Other Identifiers

17300595

Identifier Type: -

Identifier Source: org_study_id