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

Primary Purpose

Tooth Extraction

Status
Terminated
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Tranexamic Acid
Placebo
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Extraction focused on measuring Anticoagulants, Tranexamic Acid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Group

Tranexamic Acid Group

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Oral bleeding
Any oral bleeding (early or delayed; minor, clinically relevant or major)

Secondary Outcome Measures

Procedural bleeding score
Bleeding score assigned by operator (VAS 0-10)
Early bleeding
Any oral bleeding occurring after the extraction up to and including day 1 after the extraction
Delayed bleeding
Any oral bleeding occurring between day 2 and day 7
Minor bleeding
Any oral bleeding not requiring unplanned medical contact
Clinically-relevant bleeding
Any oral bleeding requiring unplanned medical contact
Major bleeding
Any oral bleeding requiring blood transfusion, hospitalization or resulting in death
The number of reinterventions
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
The number of unplanned interruptions of direct oral anticoagulant therapy

Full Information

First Posted
January 18, 2018
Last Updated
August 12, 2020
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Research Foundation Flanders
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1. Study Identification

Unique Protocol Identification Number
NCT03413891
Brief Title
Tranexamic Acid To Reduce Bleeding in Patients Treated With New Oral Anticoagulants Undergoing Dental Extraction
Acronym
EXTRACT-NOAC
Official Title
Tranexamic Acid To Reduce Bleeding in Patients Treated With New Oral Anticoagulants Undergoing Dental Extraction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
Advice from DSMB
Study Start Date
February 7, 2018 (Actual)
Primary Completion Date
March 19, 2020 (Actual)
Study Completion Date
March 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Research Foundation Flanders

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Extraction
Keywords
Anticoagulants, Tranexamic Acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Verhamme, MD, PhD
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33939696
Citation
Ockerman A, Miclotte I, Vanhaverbeke M, Vanassche T, Belmans A, Vanhove J, Meyns J, Nadjmi N, Van Hemelen G, Winderickx P, Jacobs R, Politis C, Verhamme P. Tranexamic acid and bleeding in patients treated with non-vitamin K oral anticoagulants undergoing dental extraction: The EXTRACT-NOAC randomized clinical trial. PLoS Med. 2021 May 3;18(5):e1003601. doi: 10.1371/journal.pmed.1003601. eCollection 2021 May.
Results Reference
derived

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

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