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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 17, 2020

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: reduction of bleeding events after tooth extraction compared to placebo

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

Interventions

  • Drug: Tranexamic Acid
    • Mouthwash
  • Other: Placebo
    • Mouthwash

Arms, Groups and Cohorts

  • Placebo Comparator: Control Group
    • 10mL water as mouthwash with white cherry flavor in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
  • Experimental: Tranexamic Acid Group
    • 10mL tranexamic acid mouthwash 10% in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).

Clinical Trial Outcome Measures

Primary Measures

  • Oral bleeding
    • Time Frame: 7 days: from randomization till end of follow-up
    • Any oral bleeding (early or delayed; minor, clinically relevant or major)

Secondary Measures

  • Procedural bleeding score
    • Time Frame: Day of extraction
    • Bleeding score assigned by operator (VAS 0-10)
  • Early bleeding
    • Time Frame: 1 day
    • Any oral bleeding occurring after the extraction up to and including day 1 after the extraction
  • Delayed bleeding
    • Time Frame: 6 days
    • Any oral bleeding occurring between day 2 and day 7
  • Minor bleeding
    • Time Frame: 7 days
    • Any oral bleeding not requiring unplanned medical contact
  • Clinically-relevant bleeding
    • Time Frame: 7 days
    • Any oral bleeding requiring unplanned medical contact
  • Major bleeding
    • Time Frame: 7 days
    • Any oral bleeding requiring blood transfusion, hospitalization or resulting in death
  • The number of reinterventions
    • Time Frame: 7 days
    • Any procedure in the oral cavity for the treatment of bleeding, performed by any dentist or maxillofacial surgeon
  • The number of unplanned interruptions of direct oral anticoagulant therapy
    • Time Frame: 7 days
    • The number of unplanned interruptions of direct oral anticoagulant therapy

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universitaire Ziekenhuizen Leuven
  • Collaborator
    • Research Foundation Flanders
  • Provider of Information About this Clinical Study
    • Principal Investigator: Peter Verhamme, Professor – Universitaire Ziekenhuizen Leuven
  • Overall Contact(s)
    • Peter Verhamme, MD, PhD, 003216343491, peter.verhamme@uzleuven.be

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.