Tranexamic Acid in Functional Endoscopic Sinus Surgery

Sponsor

Ain Shams University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05686005

Collaborator

(none)

159

Enrollment

Location

Arms

2.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: Oral tranexamic acid Drug: Intravenous tranexamic acid	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

159 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 3, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control No intervention
Active Comparator: Oral tranexamic The participants will receive 4 tablets of tranexamic acid 500mg (equal 2gm) 2 hours before surgery in the ward.	Drug: Oral tranexamic acid 4 tablets of tranexamic acid 500mg (equal 2gm) 2 hours before surgery in the ward.
Active Comparator: Intravenous tranexamic The participants will receive 15 mg/kg in a 20ml syringe slowly tranexamic acid during induction.	Drug: Intravenous tranexamic acid 15mg/kg of tranexamic acid in a 20ml syringe slowly intravenous during induction.

Arm

Intervention/Treatment

No Intervention: Control

No intervention

Active Comparator: Oral tranexamic

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

Drug: Oral tranexamic acid

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

Active Comparator: Intravenous tranexamic

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

Drug: Intravenous tranexamic acid

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Incidence of the common adverse effects [At 24 hours]
Postoperative nasal bleeding, nausea, and vomiting.
Post operative D-dimer [At 24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	faculty of medicine, Ain Shams University	Cairo		Egypt	11591

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tamer Samir Abdelsalam, Lecturer of Anesthesia, Ain Shams University

ClinicalTrials.gov Identifier:

NCT05686005

Other Study ID Numbers:

FMASU R 237/ 2022

First Posted:

Jan 17, 2023

Last Update Posted:

Jan 17, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tranexamic Acid

Study Results

No Results Posted as of Jan 17, 2023