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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

216 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-01

Study Completion Date

2023-12-31

Brief Summary

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Aims: To investigate the incidence of bleeding complications during oral surgical procedures in patients medicated with DOACs.

To investigate the perioperative and postoperative bleeding volume during oral surgical procedures in patients medicated with DOACs.

To examine whether increased perioperative bleeding volume complicates the planned intervention, thereby prolonging the operation time.

Previous studies have shown that the incidence of healthcare-consuming bleeding complications following oral surgical procedures in patients who are prescribed warfarin is approximately 4% (9). To investigate whether the incidence is higher or lower by the intake of DOAC it is considered to be sufficient with 100 patients in each group. The groups consist of patients who are prescribed warfarin, DOACs, as well as a control group.

Hypothetical outcomes: The incidence of bleeding complications and the perioperative and postoperative bleeding volume during oral surgical procedures in patients medicated with DOACs are higher compared to patients medicated with warfarin and patients taking no anticoagulants. Increased perioperative bleeding volume complicates the planned intervention, thereby prolonging the operation time.

Clinical relevance: The study will serve as a basis for the development of treatment guidelines for patients who medicate with DOACs. If it turns out that the oral surgery procedure presents no increased risk of complications and that the bleeding volume does not complicate the surgery significantly, it may be recommended that patients who medicate with DOACs whom are in need of oral surgical procedures seek ordinary dental care.

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Detailed Description

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The continuous variables (amount of bleeding during surgery) will be analyzed with linear regression if they show normal distribution patterns.

The ordinal variables (postoperative bleeding complications) will be analyzed with ordinal logistic regression.

Dichotomous variables (presence of other postoperative complications) will be analyzed with logistic regression.

Conditions

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Surgery, Oral Hemorrhage Postoperative Complications Oral Surgical Procedures Anticoagulants Causing Adverse Effects in Therapeutic Use Anticoagulant-induced Bleeding

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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DOAC

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Type of surgery

Intervention Type PROCEDURE

surgical or non-surgical extraction one or more teeth

Dabigatran

Intervention Type DRUG

Rivaroxaban

Intervention Type DRUG

Apixaban

Intervention Type DRUG

Edoxaban

Intervention Type DRUG

Warfarin

A PK-INR ≤3.0 retained whitin the last 24 hours have to be present for inclusion.

Type of surgery

Intervention Type PROCEDURE

surgical or non-surgical extraction one or more teeth

Warfarin

Intervention Type DRUG

Interventions

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Type of surgery

surgical or non-surgical extraction one or more teeth

Intervention Type PROCEDURE

Dabigatran

Intervention Type DRUG

Rivaroxaban

Intervention Type DRUG

Apixaban

Intervention Type DRUG

Edoxaban

Intervention Type DRUG

Warfarin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Need of dental extraction / oral surgery, and medication with:

1. warfarin or
2. DOACs or
3. no treatment or AK-platelet therapy and age-matched to group a) and b).