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

NCT06725732 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: IV & Nebulized TXA in FESS
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Patient hemodynamics.
2. 2.Anesthetic consumption, Extra doses of fentanyl and propofol and sevoflurane\>2
3. 3.Postoperative complications: including any adverse effects to TXA e.g.nausea, vomiting, any visual disturbances, fits, and any thrombotic manifestation.

Conditions

Blood Loss, Surgical

Outcome Measures

Primary Outcomes (1)

• Modena Bleeding Score- assessing surgical field

  * 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 Outcomes (12)

• Measuring patient's Blood Pressure-> mmhg (unit of measure)

  Baseline

• Measuring patient's Respiratory Rate-> breath per minute(unit of measure)

  Baseline

• Measuring patient's Temperature-> Celsius(unit of measure)

  Baseline

• Measuring patient's Pulse->Beat per minute(unit of measure)

  Baseline

• Measuring End-tidal Co2 by Capnogram

  Baseline

Study Arms (2)

Intravenous

EXPERIMENTAL

Drug: Tranexamic Acid

Nebulized

EXPERIMENTAL

Drug: Tranexamic Acid (TXA)

Interventions

Tranexamic Acid (TXA) DRUG

To see if nebulised TXA is better to control blood loss in functional Endoscopic sinus surgery

Nebulized

Tranexamic Acid DRUG

To see if intravenous TXA is better to control blood loss in functional Endoscopic sinus surgery

Intravenous

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Either sex
• age 18-65 years
• 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.
• BMI \> 35 kg/ m2

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Main building, Assiut University Hospitals

Asyut, Egypt

RECRUITING

Related Publications (4)

• Kang H, Hwang SH. Does topical application of tranexamic acid reduce intraoperative bleeding in sinus surgery during general anesthesia? Braz J Otorhinolaryngol. 2020 Jan-Feb;86(1):111-118. doi: 10.1016/j.bjorl.2019.08.006. Epub 2019 Oct 3.

  PMID: 31653606 BACKGROUND

• Khosla AJ, Pernas FG, Maeso PA. Meta-analysis and literature review of techniques to achieve hemostasis in endoscopic sinus surgery. Int Forum Allergy Rhinol. 2013 Jun;3(6):482-7. doi: 10.1002/alr.21126. Epub 2012 Dec 16.

  PMID: 23255493 BACKGROUND

• Kim DH, Kim S, Kang H, Jin HJ, Hwang SH. Efficacy of tranexamic acid on operative bleeding in endoscopic sinus surgery: A meta-analysis and systematic review. Laryngoscope. 2019 Apr;129(4):800-807. doi: 10.1002/lary.27766. Epub 2018 Dec 28.

  PMID: 30593688 BACKGROUND

• Alicandri-Ciufelli M, Pingani L, Mariano D, Anschuetz L, Molinari G, Marchioni D, Bonali M, Galeazzi GM, Presutti L. Rating surgical field quality in endoscopic ear surgery: proposal and validation of the "Modena Bleeding Score". Eur Arch Otorhinolaryngol. 2019 Feb;276(2):383-388. doi: 10.1007/s00405-018-05268-6. Epub 2019 Jan 2.

  PMID: 30604058 BACKGROUND

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Asmaa Shabaan Zanaty, Doctor

CONTACT

+201029505921; asmaa10557@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 10, 2024
• Study Start: January 29, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: January 29, 2025

Record last verified: 2024-11

Locations

EG (1)