Tranexamic Acid in Dacryocystorhinostomy

Nasolacrimal Tract Obstruction Clinical Trial

— TA-DCR  

Official title:

Single Dose Tranexamic Acid for Dacryocystorhinostomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01221909
• Other study ID #: EMC-DCR-TA
• Status: Not yet recruiting
• Phase: N/A
• First received: September 18, 2010
• Last updated: October 14, 2010
• Start date: December 2010
• Est. completion date: December 2012

Study information

• Verified date: October 2010
• Source: HaEmek Medical Center, Israel
• Contact: Haneen Jabaly-Habib, M.D.
• Phone: 972-506268059
• Email: hjabaly[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of HealthIsrael: Helsinki Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nasolacrimal Tract Obstruction

Intervention

Drug:
• Tranexamic acid
Single dose TA 500mg or placebo will be given in DCR surgery right after the first surgical incision.
• saline solution
5cc saline solution

Locations

Country	Name	City	State
Israel	Dept. of Ophthalmology, HaEmek medical center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (3)

Astedt B. Clinical pharmacology of tranexamic acid. Scand J Gastroenterol Suppl. 1987;137:22-5. Review. — View Citation

Ralley FE, Berta D, Binns V, Howard J, Naudie DD. One intraoperative dose of tranexamic Acid for patients having primary hip or knee arthroplasty. Clin Orthop Relat Res. 2010 Jul;468(7):1905-11. doi: 10.1007/s11999-009-1217-8. Epub 2010 Jan 9. Erratum in: — View Citation

Wellington K, Wagstaff AJ. Tranexamic acid: a review of its use in the management of menorrhagia. Drugs. 2003;63(13):1417-33. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	Late onset postoperative epistaxis or periorbital hematoma		8 days	Yes