Tranexamic Acid in Dacryocystorhinostomy (TA-DCR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01221909
Recruitment Status : Unknown
Verified October 2010 by HaEmek Medical Center, Israel.
Recruitment status was:  Not yet recruiting
First Posted : October 15, 2010
Last Update Posted : October 15, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Nasolacrimal Tract Obstruction Drug: Tranexamic acid Drug: saline solution Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Single Dose Tranexamic Acid for Dacryocystorhinostomy
Study Start Date : December 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. Late onset postoperative epistaxis or periorbital hematoma [ Time Frame: 8 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01221909

Contact: Haneen Jabaly-Habib, M.D. 972-506268059
Contact: Abed Mukari, M.D. 972-546881532

Dept. of Ophthalmology, HaEmek medical center Not yet recruiting
Afula, Israel, 18101
Contact: Haneen Jabaly-Habib, M.D.    972-506268059   
Contact: Abed Mukari, M.D.    972-546881532   
Sub-Investigator: Haneen Jabaly-Habib, M.D.         
Sub-Investigator: Abed Mukari, M.D.         
Principal Investigator: Daniel Briscoe, M.D.         
Sponsors and Collaborators
HaEmek Medical Center, Israel

Publications of Results:
Responsible Party: Daniel Briscoe, M.D., Chairperson of Ophthalmology Dept, EMC, Afula 18101, Israel Identifier: NCT01221909     History of Changes
Other Study ID Numbers: EMC-DCR-TA
First Posted: October 15, 2010    Key Record Dates
Last Update Posted: October 15, 2010
Last Verified: October 2010

Keywords provided by HaEmek Medical Center, Israel:
operative duration

Additional relevant MeSH terms:
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action