Assessment of Nebulized Tranexamic Acid in Functional Endoscopic Sinus Surgery Using Modena Bleeding Score

January 27, 2025 updated by: Asmaa Zanaty, Assiut University

Assessment of Nebulized Tranexamic Acid in Functional Endoscopic Sinus Surgery Using Modena Bleeding Score. a Randomized Double Blinded Controlled Trial.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Functional endoscopic sinus surgery (FESS) is the current standard treatment for a variety of conditions affecting the nasal cavity and the paranasal sinuses, such as chronic rhinosinusitis, benign and malignant tumors or cerebrospinal fluid leaks .Being mostly a one-handed technique, FESS does not allow simultaneous use of operative instruments and blood suction, thus endonasal bleeding control represents a challenging issue for the operating surgeon. Such narrow and highly vascularized cavities like the nasal fossae and paranasal spaces can be entirely filled with blood within few seconds, especially if the mucosa is severely inflamed as a consequence of rhinosinusitis. Bleeding is possibly the most relevant factor that could impair the quality of the surgical field during endoscopic procedures. It has been proven that uncontrolled bleeding during endoscopic sinus surgical procedures determines poor visualization of the anatomical landmarks, prolongs surgical time and carries a higher rate of complications .Several techniques to control intraoperative bleeding and improve surgical view during sinus surgery (e.g. topical vasoconstrictors, total intravenous anesthesia, controlled hypotension) have been described and analyzed to determine their efficacy .These types of studies, however, are complex and prone to bias, partially because standardized and validated methods of quantifying bleeding or grading the surgical field in endoscopic view are lacking.

Tranexamic acid functions as the competitive antagonist at the lysine site on plasminogen . During all surgical procedures, the tissue plasminogen activator is released due to tissue damage during surgery, which can convert tissue plasminogen to plasmin, promote fibrinolysis and activate the fibrinolytic system. Thus, tranexamic acid functions as an anti-fibrinolytic agent by inhibiting the tissue plasminogen activator. It can be applied topically or systemically with this mechanism in the coagulation cascade to reduce intraoperative bleeding .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 and compare it with intravenous tranexamic acid to improve the surgeon and patient experiences of sinus surgery.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Assiut, Egypt
        • Recruiting
        • Main building, Assiut University Hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Either sex
  2. age 18-65 years
  3. ASA I-II who are listed for elective functional endoscopic sinus surgery (FESS) under general anesthesia
  4. 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.
    • BMI > 35 kg/ m2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nebulized
Drug: Tranexamic Acid (TXA)
To see if nebulised TXA is better to control blood loss in functional Endoscopic sinus surgery
Experimental: Intravenous
Drug: Tranexamic Acid
To see if intravenous TXA is better to control blood loss in functional Endoscopic sinus surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modena Bleeding Score- assessing surgical field
Time Frame: Baseline
  • No bleeding ->1.
  • Bleeding easily controlled by suctioning, washing, or packing without any significant modification or slowing of surgical procedure->2.
  • Bleeding slowing surgical procedure->3.
  • Most of the maneuvers dedicated to bleeding control ->4.
  • Bleeding that prevents every surgical procedure except those dedicated to bleeding control->5.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring patient's Blood Pressure-> mmhg (unit of measure)
Time Frame: Baseline
Baseline
Measuring patient's Respiratory Rate-> breath per minute(unit of measure)
Time Frame: Baseline
Baseline
Measuring patient's Temperature-> Celsius(unit of measure)
Time Frame: Baseline
Baseline
Measuring patient's Pulse->Beat per minute(unit of measure)
Time Frame: Baseline
Baseline
Measuring End-tidal Co2 by Capnogram
Time Frame: Baseline
Unit of measure-> mmhg
Baseline
Measuring O2 saturation by the pulse-oximeter
Time Frame: Baseline
Baseline
Measuring amount of intraoperative bleeding through blood volume in suction jar
Time Frame: Baseline
Baseline
Measuring the amount of intraoperative bleeding by counting gauze used in the operation.
Time Frame: Baseline
Baseline
2. Anesthetic consumption, Extra doses of fentanyl and propofol and sevoflurane>2
Time Frame: Baseline
Baseline
Presence or absence of nausea as a Postoperative complication
Time Frame: Baseline
Baseline
Presence or absence of vomiting as a Postoperative complication
Time Frame: Baseline
Baseline
Presence or absence of any form of visual disturbance as a Postoperative complication
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 29, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

December 9, 2024

First Posted (Actual)

December 10, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IV & Nebulized TXA in FESS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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