Tranexamic Acid in Dacryocystorhinostomy (TA-DCR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by HaEmek Medical Center, Israel.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01221909
First received: September 18, 2010
Last updated: October 14, 2010
Last verified: October 2010
  Purpose

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 Intervention
Nasolacrimal Tract Obstruction
Drug: Tranexamic acid
Drug: saline solution

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Late onset postoperative epistaxis or periorbital hematoma [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221909

Contacts
Contact: Haneen Jabaly-Habib, M.D. 972-506268059 hjabaly@gmail.com
Contact: Abed Mukari, M.D. 972-546881532 amukari@gmail.com

Locations
Israel
Dept. of Ophthalmology, HaEmek medical center Not yet recruiting
Afula, Israel, 18101
Contact: Haneen Jabaly-Habib, M.D.    972-506268059    hjabaly@gmail.com   
Contact: Abed Mukari, M.D.    972-546881532    amukari@gmail.com   
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
  More Information

Publications:
Responsible Party: Daniel Briscoe, M.D., Chairperson of Ophthalmology Dept, EMC, Afula 18101, Israel
ClinicalTrials.gov Identifier: NCT01221909     History of Changes
Other Study ID Numbers: EMC-DCR-TA
Study First Received: September 18, 2010
Last Updated: October 14, 2010
Health Authority: Israel: Ministry of Health
Israel: Helsinki Board

Keywords provided by HaEmek Medical Center, Israel:
bleeding
dacryocystorhinostomy
operative duration

Additional relevant MeSH terms:
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 09, 2014