Tranexamic Acid to reduce bleeding in patients treated with new oral anticoagulants undergoing dental extraction (EXTRACT-NOAC)
Phase 1
- Conditions
- Patients treated with a NOAC, aged 18 years or older undergoing dental extractionTherapeutic area: Diseases [C] - Mouth and tooth diseases [C07]
- Registration Number
- EUCTR2017-001426-17-BE
- Lead Sponsor
- niversity Hospitals Leuven (Gasthuisberg)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 222
Inclusion Criteria
Patients treated with a NOAC (new oral anticoagualants), aged 18 years or older undergoing dental extraction
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 118
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 118
Exclusion Criteria
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 TXA
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate whether TXA mouthwash reduces the number of oral bleeding events in patients who undergo dental extraction and are treated with NOACs ;Secondary Objective: not applicable;Primary end point(s): Any oral bleeding after extraction (early or delayed;minor or clinically relevant).;Timepoint(s) of evaluation of this end point: DAy 0 (day of extraction) and also on day 2 and 7
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The procedural bleeding score<br>Early and delayed bleeding<br>Minor, clinically relevant and major bleeding<br>The number of reinterventions<br>The number of unplanned NOAC interruptions<br>Any non-oral bleeding<br>All thrombotic events including myocardial infarction, stroke, systemic embolism and venous thrombo-embolism<br>;Timepoint(s) of evaluation of this end point: DAy 0 (day of extraction) and also on day 2 and 7