Tranexamic Acid To Reduce Bleeding in Patients Treated With New Oral Anticoagulants Undergoing Dental Extraction

Tooth Extraction Clinical Trial

— EXTRACT-NOAC  

Official title:

Tranexamic Acid To Reduce Bleeding in Patients Treated With New Oral Anticoagulants Undergoing Dental Extraction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03413891
• Other study ID #: S60131
• Status: Terminated
• Phase: Phase 4
• Start date: February 7, 2018
• Est. completion date: March 19, 2020

Study information

• Verified date: August 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 risk of thrombo-embolic events. Therefore, an optimal strategy to minimize bleeding events after tooth extractions is required. In this study, the investigators want to assess whether adding tranexamic acid mouthwash reduces the number of bleeding events in patients treated with direct oral anticoagulants and undergoing a tooth extraction.

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: reduction of bleeding events after tooth extraction compared to placebo

• Safety: any non-oral bleeding or thrombo-embolic events

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 222
• Est. completion date: March 19, 2020
• Est. primary completion date: March 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 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 tranexamic acid

Related Conditions & MeSH terms

• Hemorrhage
• Tooth Extraction

Intervention

Drug:
• Tranexamic Acid
Mouthwash

Other:
• Placebo
Mouthwash

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Research Foundation Flanders

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety outcome: any non-oral bleeding	Any non-oral bleeding	7 days
Other	Safety outcome: thrombotic event	All thrombotic events including myocardial infarction, stroke, systemic embolism and venous thrombo-embolism	7 days
Primary	Oral bleeding	Any oral bleeding (early or delayed; minor, clinically relevant or major)	7 days: from randomization till end of follow-up
Secondary	Procedural bleeding score	Bleeding score assigned by operator (VAS 0-10)	Day of extraction
Secondary	Early bleeding	Any oral bleeding occurring after the extraction up to and including day 1 after the extraction	1 day
Secondary	Delayed bleeding	Any oral bleeding occurring between day 2 and day 7	6 days
Secondary	Minor bleeding	Any oral bleeding not requiring unplanned medical contact	7 days
Secondary	Clinically-relevant bleeding	Any oral bleeding requiring unplanned medical contact	7 days
Secondary	Major bleeding	Any oral bleeding requiring blood transfusion, hospitalization or resulting in death	7 days
Secondary	The number of reinterventions	Any procedure in the oral cavity for the treatment of bleeding, performed by any dentist or maxillofacial surgeon	7 days
Secondary	The number of unplanned interruptions of direct oral anticoagulant therapy	The number of unplanned interruptions of direct oral anticoagulant therapy	7 days