Tranexamic Acid in Dacryocystorhinostomy (TA-DCR)
Recruitment status was: Not yet recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Single Dose Tranexamic Acid for Dacryocystorhinostomy|
- Duration of DCR surgery in minutes and amount of blood loss in milliliters during surgery. [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
- Late onset postoperative epistaxis or periorbital hematoma [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|Experimental: Tranexamic acid single dose of 500mg||
Drug: Tranexamic acid
Single dose TA 500mg or placebo will be given in DCR surgery right after the first surgical incision.
|Placebo Comparator: Saline||
Drug: saline solution
5cc saline solution
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221909
|Dept. of Ophthalmology, HaEmek medical center|
|Afula, Israel, 18101|