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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-07

Study Completion Date

2020-03-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intra- and Post- Operative Bleeding After Simple Dental Extraction in Direct Oral Anticoagulant Therapy

NCT03124030

Anticoagulant-induced Bleeding Dental Diseases

UNKNOWN

Effect of TXA Oral Sol 5% in Patients Treated With DOACs or VKA and Undergoing a Single or Multiple Tooth Extraction

NCT06143787

Bleeding From Teeth Bleeding Prophylaxis

RECRUITING PHASE3

The Effect on Blood Loss of Topical and Intravenous Tranexamic Acid in Cardiac Surgery Patients

NCT01895101

Blood Loss Tranexamic Acid Cardiac Surgery

COMPLETED PHASE4

NOACs in Oral and Maxillofacial Surgery: Impact on Post-operative Complications

NCT04662515

Surgery, Oral Hemorrhage Postoperative Complications +3 more

COMPLETED

The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery

NCT03433144

Tranexamic Acid Orthognathic Surgery

WITHDRAWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tooth Extraction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Mouthwash

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).

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

Mouthwash

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tranexamic Acid

Mouthwash

Intervention Type DRUG

Placebo

Mouthwash

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Exacyl

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No