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Completed

NCT Number: NCT05686005

Tranexamic Acid in Functional Endoscopic Sinus Surgery

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.

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Key information

Conditions

Anesthesia

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

faculty of medicine, Ain Shams University

Cairo, 11591, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

oral tranexamic acid

Drug

4 tablets of tranexamic acid 500mg (equal 2gm) 2 hours before surgery in the ward.

Intravenous tranexamic acid

Drug

15mg/kg of tranexamic acid in a 20ml syringe slowly intravenous during induction.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Incidence of the common adverse effects

    Time frame: At 24 hours

    Postoperative nasal bleeding, nausea, and vomiting.

  2. Post operative D-dimer

    Time frame: At 24 hours

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 17, 2023
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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