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OpenTrials
Completed

NCT Number: NCT06365242

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

Evaluation of DOACs treatment on post-extraction bleeding

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Key information

Conditions

Post Operative Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

U.O. Odontostomatologia e Chirurgia del Cavo Orale

Pisa, 56126, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Peri-operative hemorrhage

    Time frame: 20 minutes to 80 minutes

    Evaluation of early post-operative hemorrhage classified as absent, mild, oozing, moderate, and severe.

  2. Post-operative bleeding

    Time frame: day 1 to 7 post-operatively

    Evaluation of post-operative bleeding classified as absent, mild, oozing, moderate, and severe.

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Acronym: DOACS_1

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 15, 2024
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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