Tranexamic Acid in Functional Endoscopic Sinus Surgery

May 1, 2023 updated by: Tamer Samir Abdelsalam, Ain Shams University

The Efficacy of Oral Versus Intravenous Tranexamic Acid in Functional Endoscopic Sinus Surgery. A Prospective, Randomized, Double-blind Controlled Trial.

The purpose of the study is to compare the effect of oral tranexamic acid vs. intravenous in decreasing bleeding and improving the field during FESS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The use of tranexamic acid during Intraoperative bleeding in functional endoscopic sinus surgery (FESS) improves the outcome. Bleeding is one of the most devastating complications during fess. Tranexamic acid is used in open heart surgery to improve the surgical field.

Using oral vs. intravenous forms of the drug will add to our knowledge and improve outcomes.

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Phase 4

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 Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 11591
        • Faculty of Medicine, Ain Shams University

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • American Society of Anesthesiologists grade I or II.
  • Sex: Both sexes.
  • Age between 18 and 40 years.
  • Patients scheduled for FESS under general anesthesia.

Exclusion Criteria:

  • Declining to give written informed consent.
  • History of allergy to the medications used in the study.
  • History of venous or arterial thrombosis.
  • history of cardiovascular diseases including AF, IHD, or hypertension.
  • History of chest problems including pulmonary embolism, bronchial asthma and COPD.
  • History of cerebrovascular stroke.
  • History of drug or alcohol abuse.
  • Taking opioids or sedative medications.
  • Hepatic or renal failure.
  • Bleeding disorders, antiplatelets (aspirin, clopidogrel) or anticoagulant (warfarin).

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No intervention
Active Comparator: Oral tranexamic
The participants will receive 4 tablets of tranexamic acid 500mg (equal 2gm) 2 hours before surgery in the ward.
Drug: Oral tranexamic acid
4 tablets of tranexamic acid 500mg (equal 2gm) 2 hours before surgery in the ward.
Active Comparator: Intravenous tranexamic
The participants will receive 15 mg/kg in a 20ml syringe slowly tranexamic acid during induction.
Drug: Intravenous tranexamic acid
15mg/kg of tranexamic acid in a 20ml syringe slowly intravenous during induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative field bleeding
Time Frame: At 30 minutes after surgery start
The Wormald grading system for bleeding during endoscopic sinus surgery (0= no bleeding and 10= severe bleeding with sphenoid fills < 10 seconds)
At 30 minutes after surgery start

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of the common adverse effects
Time Frame: At 24 hours
Postoperative nasal bleeding, nausea, and vomiting.
At 24 hours
Post operative D-dimer
Time Frame: At 24 hours
At 24 hours

Collaborators and Investigators

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

Sponsor

Ain Shams University

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 (Actual)

December 3, 2022

Primary Completion (Actual)

April 29, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

January 6, 2023

First Submitted That Met QC Criteria

January 6, 2023

First Posted (Actual)

January 17, 2023

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 1, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU R 237/ 2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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