Tranexamic Acid in Dacryocystorhinostomy

NCT ID: NCT01221909

Last Updated: 2010-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nasolacrimal Tract Obstruction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tranexamic acid single dose of 500mg

Group Type EXPERIMENTAL

Tranexamic acid

Intervention Type DRUG

Single dose TA 500mg or placebo will be given in DCR surgery right after the first surgical incision.

Saline

Group Type PLACEBO_COMPARATOR

saline solution

Intervention Type DRUG

5cc saline solution

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tranexamic acid

Single dose TA 500mg or placebo will be given in DCR surgery right after the first surgical incision.

Intervention Type DRUG

saline solution

5cc saline solution

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chairperson of Ophthalmology Dept, EMC, Afula 18101, Israel

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dept. of Ophthalmology, HaEmek medical center

Afula, Afula, Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Haneen Jabaly-Habib, M.D.

Role: CONTACT

972-506268059

Abed Mukari, M.D.

Role: CONTACT

972-546881532

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Haneen Jabaly-Habib, M.D.

Role: primary

972-506268059

Abed Mukari, M.D.

Role: backup

972-546881532

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 20063079 (View on PubMed)

Wellington K, Wagstaff AJ. Tranexamic acid: a review of its use in the management of menorrhagia. Drugs. 2003;63(13):1417-33. doi: 10.2165/00003495-200363130-00008.

Reference Type RESULT
PMID: 12825966 (View on PubMed)

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

Reference Type RESULT
PMID: 3321402 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EMC-DCR-TA

Identifier Type: -

Identifier Source: org_study_id