Tranexamic Acid in Functional Endoscopic Sinus Surgery

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05686005

Enrollment

159

Registered

2023-01-17

Start date

2022-12-03

Completion date

2023-04-30

Last updated

2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Brief summary

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.

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.

Interventions

DRUGOral tranexamic acid

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

DRUGIntravenous tranexamic acid

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
Intraoperative field bleeding	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

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026