- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01221909
Tranexamic Acid in Dacryocystorhinostomy (TA-DCR)
October 14, 2010 updated by: HaEmek Medical Center, Israel
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Haneen Jabaly-Habib, M.D.
- Phone Number: 972-506268059
- Email: hjabaly@gmail.com
Study Contact Backup
- Name: Abed Mukari, M.D.
- Phone Number: 972-546881532
- Email: amukari@gmail.com
Study Locations
-
-
-
Afula, Israel, 18101
- Dept. of Ophthalmology, HaEmek medical center
-
Contact:
- Haneen Jabaly-Habib, M.D.
- Phone Number: 972-506268059
- Email: hjabaly@gmail.com
-
Contact:
- Abed Mukari, M.D.
- Phone Number: 972-546881532
- Email: amukari@gmail.com
-
Sub-Investigator:
- Haneen Jabaly-Habib, M.D.
-
Sub-Investigator:
- Abed Mukari, M.D.
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Principal Investigator:
- Daniel Briscoe, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Saline
|
5cc saline solution
|
Experimental: Tranexamic acid single dose of 500mg
|
Single dose TA 500mg or placebo will be given in DCR surgery right after the first surgical incision.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
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
Outcome Measure |
Time Frame |
---|---|
Late onset postoperative epistaxis or periorbital hematoma
Time Frame: 8 days
|
8 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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: Clin Orthop Relat Res. 2010 May;468(5):1447.
- 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.
- Astedt B. Clinical pharmacology of tranexamic acid. Scand J Gastroenterol Suppl. 1987;137:22-5.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Anticipated)
December 1, 2012
Study Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
September 18, 2010
First Submitted That Met QC Criteria
October 14, 2010
First Posted (Estimate)
October 15, 2010
Study Record Updates
Last Update Posted (Estimate)
October 15, 2010
Last Update Submitted That Met QC Criteria
October 14, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMC-DCR-TA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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