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

September 18, 2010
October 14, 2010
December 2010
December 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01221909 on ClinicalTrials.gov Archive Site
Late onset postoperative epistaxis or periorbital hematoma [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Tranexamic Acid in Dacryocystorhinostomy
Single Dose Tranexamic Acid for Dacryocystorhinostomy

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Nasolacrimal Tract Obstruction
  • Drug: Tranexamic acid
    Single dose TA 500mg or placebo will be given in DCR surgery right after the first surgical incision.
  • Drug: saline solution
    5cc saline solution
  • Experimental: Tranexamic acid single dose of 500mg
    Intervention: Drug: Tranexamic acid
  • Placebo Comparator: Saline
    Intervention: Drug: saline solution

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
80
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Haneen Jabaly-Habib, M.D. 972-506268059 hjabaly@gmail.com
Contact: Abed Mukari, M.D. 972-546881532 amukari@gmail.com
Israel
 
NCT01221909
EMC-DCR-TA
Not Provided
Daniel Briscoe, M.D., Chairperson of Ophthalmology Dept, EMC, Afula 18101, Israel
HaEmek Medical Center, Israel
Not Provided
Not Provided
HaEmek Medical Center, Israel
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP