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

Malmö University

Status: Completed

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

Treatments: Drug: Warfarin; Drug: Rivaroxaban; Drug: Edoxaban; Procedure: Type of surgery; Drug: Dabigatran; Drug: Apixaban

Study type: Observational

Funder types: Other

Identifiers

NCT04662515

AK-BLD

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 216 patients

Sex: All

Volunteers: No Healthy Volunteers

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).

Exclusion criteria

Medication with the combination of anticoagulants and antiplatelet Ongoing drug abuse

Trial design

216 participants in 2 patient groups

DOAC

Description:

Information about which type of DOAC and the dose that is prescribed to the patient will be collected.

Treatment:

Drug: Apixaban

Drug: Dabigatran

Procedure: Type of surgery

Drug: Edoxaban

Drug: Rivaroxaban

Warfarin

Description:

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

Treatment:

Procedure: Type of surgery

Drug: Warfarin