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

Completed

• Conditions: Anticoagulant-induced Bleeding; Surgery, Oral; Hemorrhage; Oral Surgical Procedures; Postoperative Complications; Anticoagulants Causing Adverse Effects in Therapeutic Use
• Interventions: Procedure: Type of surgery; Drug: Dabigatran; Drug: Warfarin; Drug: Rivaroxaban; Drug: Apixaban; Drug: Edoxaban

• Registration Number: NCT04662515
• Lead Sponsor: Malmö University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2020-12-04
• Study First Submitted QC: 2020-12-04
• Study First Posted: 2020-12-10
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Warfarin	Type of surgery	A PK-INR ≤3.0 retained whitin the last 24 hours have to be present for inclusion.
DOAC	Type of surgery	Information about which type of DOAC and the dose that is prescribed to the patient will be collected.
DOAC	Edoxaban	Information about which type of DOAC and the dose that is prescribed to the patient will be collected.
DOAC	Rivaroxaban	Information about which type of DOAC and the dose that is prescribed to the patient will be collected.
DOAC	Apixaban	Information about which type of DOAC and the dose that is prescribed to the patient will be collected.
DOAC	Dabigatran	Information about which type of DOAC and the dose that is prescribed to the patient will be collected.
Warfarin	Warfarin	A PK-INR ≤3.0 retained whitin the last 24 hours have to be present for inclusion.

Primary Outcome Measures

Name	Time	Method
bleeding complication	4 weeks postoperatively	proportion of patients who are in need of non planned/emergency medical or dental care after tooth extraction / oral surgery because of bleeding

Secondary Outcome Measures

Name	Time	Method
bleeding volume	the actual time of surgery	the amount of blood that the patient is bleeding during tooth extraction / oral surgery
proportion of other postoperative complications	4 weeks postoperatively
surgical difficulty	the actual time of surgery	estimation on a scale of 1-10 by the surgeon
surgery time in minutes	the actual time of surgery

Trial Locations

Locations (2)

Skåne University Hospital; 🇸🇪 Helsingborg, Sweden

Department of Oral and Maxillofacial Surgery and Oral Medicine, Faculty of Odontology, Malmö University; 🇸🇪 Malmö, Sweden