Direct Oral Anticoagulants and Management of Blleding Following Dental Extractions. A Prospective Cohort Study. (DOACS_1)

May 8, 2024 updated by: Antonio Barone, University of Pisa
Evaluation of DOACs treatment on post-extraction bleeding

Study Overview

Status

Completed

Conditions

Detailed Description

Consecutive patients requiring at least one dental extraction were enrolled. DOACs regimen was either maintained or suspended. Patients were classified in subgroups depending on the number of teeth extracted per procedure (≤ 3 or > 3), the need for flap raising and the performance of osteotomy. Bleeding was recorded intraoperatively, perioperatively at 20, 40, 60 and 80 minutes after the procedure, and in the first seven days post-operatively.

Study Type

Observational

Enrollment (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pisa, Italy, 56126
        • U.O. Odontostomatologia e Chirurgia del Cavo Orale

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients referred to the Unit of Dentistry and Oral Surgery for dental extraction between 2021 and 2023 were enrolled in this study. All the study participants signed an informed consent form to be included in the study.

Description

Inclusion Criteria:

  • age >18 years
  • patients under pharmacological treatment with DOACs
  • patients requiring at least one dental extraction
  • patients willing to take part in the study and to sign informed consent

Exclusion Criteria:

  • patients below 18 years of age
  • patients treated with antiplatelet therapy or vitamin K antagonists
  • patients presenting with an International Normalized Ratio (INR) >3.0
  • patients suffering from congenital or acquired coagulopathies (e.g. haemophilia, coagulation factors deficiency, von Willebrand disease, thrombocytopenia, cirrhosis)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
DOACs treated patients
Patients treated with DOACs undergoing oral extractions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peri-operative hemorrhage
Time Frame: 20 minutes to 80 minutes
Evaluation of early post-operative hemorrhage classified as absent, mild, oozing, moderate, and severe.
20 minutes to 80 minutes
Post-operative bleeding
Time Frame: day 1 to 7 post-operatively
Evaluation of post-operative bleeding classified as absent, mild, oozing, moderate, and severe.
day 1 to 7 post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pisa

Investigators

  • Principal Investigator: Antonio Barone, University of Pisa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2020

Primary Completion (Actual)

July 27, 2021

Study Completion (Actual)

December 23, 2022

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 9, 2024

First Posted (Actual)

April 15, 2024

Study Record Updates

Last Update Posted (Actual)

May 10, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOACS1_2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be available as aggregate and anonymous data for sceintific publication purposes.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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