Nebulized Tranexamic Acid in Sinus Surgery

• Sponsor: Assiut University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04905901
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 19.6
• Patients Per Site Per Month: 4.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bleeding Nose	Drug: Tranexamic acid; Other: Saline placebo	Phase 3

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)

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Does Nebulized Tranexamic Acid Affect Operative Field in Sinus Surgery? A Double Blind Randomized Clinical Trial
• Actual Study Start Date: May 6, 2021
• Anticipated Primary Completion Date: Dec 20, 2022
• Anticipated Study Completion Date: Dec 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tranexamic acid 500 mg Nebulized tranexamic acid 500 mg 15 minutes before operation	Drug: Tranexamic acid; Tranexamic acid nebulization 15 minutes before sinus surgery; Other Names: Cyclokapron
Experimental: Tranexamic acid 1gm Nebulized tranexamic acid 1 gm 15 minutes before operation	Drug: Tranexamic acid; Tranexamic acid nebulization 15 minutes before sinus surgery; Other Names: Cyclokapron
Placebo Comparator: Saline placebo Normal saline nebulization 15 minutes before operation	Other: Saline placebo; Normal saline placebo nebulization 15 minutes before sinus surgery

Outcome Measures

Primary Outcome Measures

1. the Modena Bleeding Score (MBS) assessing surgical field [After anesthesia induction to 60 minute]

   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

Secondary Outcome Measures

1. HR [Intraoperative duration]

   Heart rate beat/min

2. MBP [Intraoperative duration]

   Mean blood pressure mmHg

3. Anesthetic consumption [Anesthesia duration]

   Extra doses of fentanyl and propofol and sevoflurane>2

4. Postoperative complications [After operation to 24 hour]

   Recording any adverse effects to TXA e.g.nausea, vomiting and any visual disturbances

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assuit	Assiut	Assuit	Egypt	Assuit universi

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Omar Makram Soliman, Egypt Assuit university hospital, Assiut University
• ClinicalTrials.gov Identifier: NCT04905901
• Other Study ID Numbers: 17300595
• First Posted: May 28, 2021
• Last Update Posted: Mar 29, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Epistaxis; Tranexamic Acid

Study Results

No Results Posted as of Mar 29, 2022