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

• Sponsor: Universitaire Ziekenhuizen Leuven (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03413891
• Collaborator: Research Foundation Flanders (Other)
• Enrollment: 222
• Location: 1
• Arms: 2
• Actual Duration (Months): 25.3
• Patients Per Site Per Month: 8.8

Study Details

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.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 222 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: Feb 7, 2018
• Actual Primary Completion Date: Mar 19, 2020
• Actual Study Completion Date: Mar 19, 2020

Arms and Interventions

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 Names: Exacyl

Outcome Measures

Primary Outcome Measures

1. Oral bleeding [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 [Day of extraction]

   Bleeding score assigned by operator (VAS 0-10)

2. Early bleeding [1 day]

   Any oral bleeding occurring after the extraction up to and including day 1 after the extraction

3. Delayed bleeding [6 days]

   Any oral bleeding occurring between day 2 and day 7

4. Minor bleeding [7 days]

   Any oral bleeding not requiring unplanned medical contact

5. Clinically-relevant bleeding [7 days]

   Any oral bleeding requiring unplanned medical contact

6. Major bleeding [7 days]

   Any oral bleeding requiring blood transfusion, hospitalization or resulting in death

7. The number of reinterventions [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 [7 days]

   The number of unplanned interruptions of direct oral anticoagulant therapy

Other Outcome Measures

1. Safety outcome: any non-oral bleeding [7 days]

   Any non-oral bleeding

2. Safety outcome: thrombotic event [7 days]

   All thrombotic events including myocardial infarction, stroke, systemic embolism and venous thrombo-embolism

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Leuven	Leuven		Belgium	3000

Sponsors and Collaborators

• Universitaire Ziekenhuizen Leuven
• Research Foundation Flanders

Investigators

• Principal Investigator: Peter Verhamme, MD, PhD, UZ Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peter Verhamme, Professor, Universitaire Ziekenhuizen Leuven
• ClinicalTrials.gov Identifier: NCT03413891
• Other Study ID Numbers: S60131
• First Posted: Jan 29, 2018
• Last Update Posted: Aug 17, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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, Professor, Universitaire Ziekenhuizen Leuven: Anticoagulants; Tranexamic Acid
• Additional relevant MeSH terms: Hemorrhage; Tranexamic Acid

Study Results

No Results Posted as of Aug 17, 2020