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Tranexamic Acid To Reduce Bleeding in Patients Treated With New Oral Anticoagulants Undergoing Dental Extraction (EXTRACT-NOAC)

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ClinicalTrials.gov Identifier: NCT03413891
Recruitment Status : Recruiting
First Posted : January 29, 2018
Last Update Posted : January 29, 2018
Sponsor:
Collaborator:
Research Foundation Flanders
Information provided by (Responsible Party):
Peter Verhamme, Universitaire Ziekenhuizen Leuven

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 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.

Condition or disease Intervention/treatment Phase
Tooth Extraction Drug: Tranexamic Acid Other: Placebo Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tranexamic Acid To Reduce Bleeding in Patients Treated With New Oral Anticoagulants Undergoing Dental Extraction
Actual Study Start Date : January 17, 2018
Estimated Primary Completion Date : January 17, 2020
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
Other: Placebo
Mouthwash

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).
Drug: Tranexamic Acid
Mouthwash
Other Name: Exacyl




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Procedural bleeding score [ Time Frame: Day of extraction ]
    Bleeding score assigned by operator (VAS 0-10)

  2. Early bleeding [ Time Frame: 1 day ]
    Any oral bleeding occurring after the extraction up to and including day 1 after the extraction

  3. Delayed bleeding [ Time Frame: 6 days ]
    Any oral bleeding occurring between day 2 and day 7

  4. Minor bleeding [ Time Frame: 7 days ]
    Any oral bleeding not requiring unplanned medical contact

  5. Clinically-relevant bleeding [ Time Frame: 7 days ]
    Any oral bleeding requiring unplanned medical contact

  6. Major bleeding [ Time Frame: 7 days ]
    Any oral bleeding requiring blood transfusion, hospitalization or resulting in death

  7. 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

  8. The number of unplanned interruptions of direct oral anticoagulant therapy [ Time Frame: 7 days ]
    The number of unplanned interruptions of direct oral anticoagulant therapy


Other Outcome Measures:
  1. Safety outcome: any non-oral bleeding [ Time Frame: 7 days ]
    Any non-oral bleeding

  2. Safety outcome: thrombotic event [ Time Frame: 7 days ]
    All thrombotic events including myocardial infarction, stroke, systemic embolism and venous thrombo-embolism



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03413891


Contacts
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Contact: Peter Verhamme, MD, PhD 003216343491 peter.verhamme@uzleuven.be
Contact: Valérie Robesyn 003216341949 blv@uzleuven.be

Locations
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Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Contact: Peter Verhamme, MD, PhD    003216343491    peter.verhamme@uzleuven.be   
Sub-Investigator: Constantinus Politis, MD, PhD         
Sub-Investigator: Anna Ockerman, MSc         
Sub-Investigator: Thomas Vanassche, MD, PhD         
Sub-Investigator: Isabel Miclotte, MD         
Sub-Investigator: Maarten Vanhaverbeke, MD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Research Foundation Flanders

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Responsible Party: Peter Verhamme, Professor, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03413891     History of Changes
Other Study ID Numbers: S60131
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Peter Verhamme, Universitaire Ziekenhuizen Leuven:
Anticoagulants
Tranexamic Acid
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Tranexamic Acid
Anticoagulants
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants