MedTrace Logo

Oral Anticoagulant Peri-procedural Management in Patients Undergoing an Oral Surgery, Implantology or Periodontology

NCT03150303 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 532

Last updated 2020-08-19

No results posted yet for this study

Summary

Patients receiving long-term oral anticoagulant (defined as duration of treatment of at least 1 month of Direct Oral Anticoagulant (DAOC) or Vitamin K Antagonist (VKA)) and referred for an invasive procedure (oral surgery, implantology or periodontology) to an oral surgeon taking part to the study will be included in this prospective observational study.

The main composite outcome is the occurrence rate of hemorrhagic and/or thromboembolic events during the peri-procedural period (between 5 days before surgery plus 30 days after the invasive procedure).

0\. The secondary end-points will consist of identifying risk factors for bleeding during the peri-procedural period, risk factors for thromboembolic events during the peri-procedural period, the peri-procedural management of each treatment (VKA or DOAC), the prescribers involved in the possible change of anticoagulant prescription prior the oral surgery All outcome events will be blindly adjudicated by a central independent adjudication committee.

Conditions

  • Oral Anticoagulants
  • Invasive Procedure

Sponsors & Collaborators

Principal Investigators

  • Isabelle Mahé, MD, PhD · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-04
Primary Completion
2017-07-04
Completion
2020-01-10

Countries

  • France

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03150303 on ClinicalTrials.gov