Tranexamic Acid to reduce bleeding in patients treated with new oral anticoagulants undergoing dental extraction (EXTRACT-NOAC)

Tranexamic Acid to reduce bleeding in patients treated with new oral anticoagulants undergoing dental extraction (EXTRACT-NOAC) - Extract-NOAC

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001426-17-BE

Enrollment

236

Registered

2017-12-06

Start date

2018-01-03

Completion date

Unknown

Last updated

2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients treated with a NOAC, aged 18 years or older undergoing dental extraction

Interventions

Trade Name: Exacyl Product Name: exacyl Pharmaceutical Form: Oral solution INN or Proposed INN: tranexamic acid Other descriptive name: TRANEXAMIC ACID Concentration unit: g/ml gram(s)/millilitre Conc

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): The procedural bleeding score Early and delayed bleeding Minor, clinically relevant and major bleeding The number of reinterventions The number of unplanned NOAC interruptions Any non-oral bleeding All thrombotic events including myocardial infarction, stroke, systemic embolism and venous thrombo-embolism ;Timepoint(s) of evaluation of this end point: DAy 0 (day of extraction) and also on day 2 and 7	—

Measure

Time frame

Secondary end point(s): The procedural bleeding score Early and delayed bleeding Minor, clinically relevant and major bleeding The number of reinterventions The number of unplanned NOAC interruptions Any non-oral bleeding All thrombotic events including myocardial infarction, stroke, systemic embolism and venous thrombo-embolism ;Timepoint(s) of evaluation of this end point: DAy 0 (day of extraction) and also on day 2 and 7

—

Countries

Belgium

Contacts

Public ContactValerie Robesyn/ Barbara Debaveye

Universitary Hospitals Leuven (Gasthuisberg)

barbara.debaveye@uzleuven.be03216341463

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026