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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05686005
Other study ID # FMASU R 237/ 2022
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 3, 2022
Est. completion date April 30, 2023

Study information

Verified date May 2023
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 159
Est. completion date April 30, 2023
Est. primary completion date April 29, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Oral tranexamic acid
4 tablets of tranexamic acid 500mg (equal 2gm) 2 hours before surgery in the ward.
Intravenous tranexamic acid
15mg/kg of tranexamic acid in a 20ml syringe slowly intravenous during induction.

Locations

Country Name City State
Egypt faculty of medicine, Ain Shams University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intraoperative field bleeding 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 Incidence of the common adverse effects Postoperative nasal bleeding, nausea, and vomiting. At 24 hours
Secondary Post operative D-dimer At 24 hours
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