Tranexamic Acid in Dacryocystorhinostomy
TA-DCR
Single Dose Tranexamic Acid for Dacryocystorhinostomy
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2010
CompletedFirst Posted
Study publicly available on registry
October 15, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedOctober 15, 2010
October 1, 2010
2 years
September 18, 2010
October 14, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Duration of DCR surgery in minutes and amount of blood loss in milliliters during surgery.
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 Outcomes (1)
Late onset postoperative epistaxis or periorbital hematoma
8 days
Study Arms (2)
Tranexamic acid single dose of 500mg
EXPERIMENTALSaline
PLACEBO COMPARATORInterventions
Single dose TA 500mg or placebo will be given in DCR surgery right after the first surgical incision.
Eligibility Criteria
You may qualify if:
- obstruction of nasolacrimal pathway
- eligible for DCR surgery
- years of age or older
You may not qualify if:
- warfarin treatment
- renal insufficiency
- pregnancy
- mental retardation
- tendency to bleed
- thromboembolic disease
- thrombophilia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept. of Ophthalmology, HaEmek medical center
Afula, Afula, 18101, Israel
Related Publications (3)
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.
PMID: 20063079RESULTWellington 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.
PMID: 12825966RESULTAstedt B. Clinical pharmacology of tranexamic acid. Scand J Gastroenterol Suppl. 1987;137:22-5.
PMID: 3321402RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 18, 2010
First Posted
October 15, 2010
Study Start
December 1, 2010
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
October 15, 2010
Record last verified: 2010-10