Trial intelligence / Profile preview

Oral vs Intravenous Tranexamic Acid in FESS

NCT05686005Phase 4

Key facts

Status
Completed
Start
Dec 2022
Primary completion
Apr 2023
Countries
1
Sponsor
Ain Shams University
Modality
Small Molecules
Conditions
intraoperative bleeding
01

Overview

Phase 4, randomised, double-blind trial of tranexamic acid in intraoperative bleeding (3 arms), sponsored by Ain Shams University. Primary endpoint: Intraoperative field bleeding. Started Dec 2022; status: completed.

02

Design

3 arms
Study design
RandomizedDouble-blind
  • Control

    No intervention

  • Oral tranexamic

    Oral tranexamic acid 2gm 2 hours before surgery

  • Intravenous tranexamic

    Intravenous tranexamic acid 15mg/kg during induction

03

Who it enrols

Adults aged 18-40 scheduled for FESS under general anesthesia with ASA grade I or II, excluding those with history of thrombosis, cardiovascular diseases, chest problems, stroke, hepatic/renal failure, bleeding disorders, or taking opioids, sedatives, antiplatelets, or anticoagulants.

04

Endpoints

Primary

  • Intraoperative field bleeding

Secondary

  • Incidence of the common adverse effects

  • Post operative D-dimer

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