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.
1 other identifier
interventional
159
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2022
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 3, 2022
CompletedFirst Submitted
Initial submission to the registry
January 6, 2023
CompletedFirst Posted
Study publicly available on registry
January 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedMay 3, 2023
May 1, 2023
5 months
January 6, 2023
May 1, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Incidence of the common adverse effects
At 24 hours
Post operative D-dimer
At 24 hours
Study Arms (3)
Control
NO INTERVENTIONNo intervention
Oral tranexamic
ACTIVE COMPARATORThe participants will receive 4 tablets of tranexamic acid 500mg (equal 2gm) 2 hours before surgery in the ward.
Intravenous tranexamic
ACTIVE COMPARATORThe participants will receive 15 mg/kg in a 20ml syringe slowly tranexamic acid during induction.
Interventions
4 tablets of tranexamic acid 500mg (equal 2gm) 2 hours before surgery in the ward.
15mg/kg of tranexamic acid in a 20ml syringe slowly intravenous during induction.
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists grade I or II.
- Sex: Both sexes.
- Age between 18 and 40 years.
- Patients scheduled for FESS under general anesthesia.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
faculty of medicine, Ain Shams University
Cairo, 11591, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Anesthesia
Study Record Dates
First Submitted
January 6, 2023
First Posted
January 17, 2023
Study Start
December 3, 2022
Primary Completion
April 29, 2023
Study Completion
April 30, 2023
Last Updated
May 3, 2023
Record last verified: 2023-05