Tranexamic Acid in Dacryocystorhinostomy

Not Applicable

• Conditions: Nasolacrimal Tract Obstruction
• Interventions: Drug: Tranexamic acid; Drug: saline solution

• Registration Number: NCT01221909
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

Single dose tranexamic acid (TA) before dacryocystorhinostomy (DCR) operation: a prospective, double blind, placebo controlled study.

The study hypothesis: TA in DCR might reduce the intraoperative and postoperative bleeding in DCR surgery, and might reduce the duration of the surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-18
• Status Verified: 2010-10
• Study First Submitted QC: 2010-10-14
• Last Update Submitted: 2010-10-14
• Study First Posted: 2010-10-15
• Last Update Posted: 2010-10-15
• Study Start: 2010-12
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• obstruction of nasolacrimal pathway
• eligible for DCR surgery
• 18 years of age or older

Exclusion Criteria

• warfarin treatment
• renal insufficiency
• pregnancy
• mental retardation
• tendency to bleed
• thromboembolic disease
• thrombophilia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tranexamic acid single dose of 500mg	Tranexamic acid	-
Saline	saline solution	-

Primary Outcome Measures

Name	Time	Method
Duration of DCR surgery in minutes and amount of blood loss in milliliters during surgery.	Blood loss will be measured at the end of DCR operation from the suction bowel. Duration of surgery will be caculated by registering time of operation start and end.

Secondary Outcome Measures

Name	Time	Method
Late onset postoperative epistaxis or periorbital hematoma	8 days

Trial Locations

Locations (1)

Dept. of Ophthalmology, HaEmek medical center; 🇮🇱 Afula, Israel