Status:
TERMINATED
Tranexamic Acid To Reduce Bleeding in Patients Treated With New Oral Anticoagulants Undergoing Dental Extraction
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
Research Foundation Flanders
Conditions:
Tooth Extraction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
In patients treated with direct oral anticoagulants, bleeding events during or after tooth extraction can lead to unscheduled interruption of the antithrombotic treatment and a potential increased ris...
Detailed Description
Interventional phase IV, randomized, double-blind, placebo-controlled trial: * Feasibility: a 3-day regimen of tranexamic acid mouthwash in patients treated with direct oral anticoagulants * Efficacy...
Eligibility Criteria
Inclusion
- Patients scheduled for dental extraction and treated with edoxaban, apixaban, rivaroxaban or dabigatran
- Not having taken the direct oral anticoagulant on the day of the extraction
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion
- Subjects with any condition that as judged by the Investigator would place the subject at increased risk of harm if he/she participated in the study.
- Pregnancy or lactation
- Known allergic reaction to tranexamic acid
Key Trial Info
Start Date :
February 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2020
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT03413891
Start Date
February 7 2018
End Date
March 19 2020
Last Update
August 1 2024
Active Locations (1)
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1
University Hospitals Leuven
Leuven, Belgium, 3000