Tranexamic Acid in Functional Endoscopic Sinus Surgery

NCT ID: NCT05686005

Last Updated: 2023-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-03

Study Completion Date

2023-04-30

Brief Summary

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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

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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.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Oral tranexamic

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

Group Type ACTIVE_COMPARATOR

Oral tranexamic acid

Intervention Type DRUG

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

Intravenous tranexamic

The participants will receive 15 mg/kg in a 20ml syringe slowly tranexamic acid during induction.

Group Type ACTIVE_COMPARATOR

Intravenous tranexamic acid

Intervention Type DRUG

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

Interventions

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Oral tranexamic acid

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

Intervention Type DRUG

Intravenous tranexamic acid

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

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Tamer Samir Abdelsalam

Lecturer of Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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faculty of medicine, Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FMASU R 237/ 2022

Identifier Type: -

Identifier Source: org_study_id

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