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

Novel Oral Anticoagulants in Oral and Maxillofacial Surgery: Impact on Bleeding Tendency, Surgical Difficulty and Post-operative Complications

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 216

Contacts and Locations

Study Locations

• Sweden
  • Helsingborg, Sweden, SE - 251 87
    • Skane University Hospital
  • Malmö, Sweden, S-20506
    • Department of Oral and Maxillofacial Surgery and Oral Medicine, Faculty of Odontology, Malmö University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients referred to either the oral surgery department at Skåne University hospital or the department for Oral surgery and oral medicine, Malmö University.

The plan is to ask all patients consecutively referred to the clinics for participation.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
DOAC; Information about which type of DOAC and the dose that is prescribed to the patient will be collected.	Drug: Dabigatran; Drug: Apixaban; Drug: Rivaroxaban; Drug: Edoxaban; Procedure: Type of surgery; surgical or non-surgical extraction one or more teeth
Warfarin; A PK-INR ≤3.0 retained whitin the last 24 hours have to be present for inclusion.	Drug: Warfarin; Procedure: Type of surgery; surgical or non-surgical extraction one or more teeth

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Malmö University
• Collaborators: Odontologisk Forskning i Region Skåne (OFRS)
• Investigators: Study Director: Jonas P becktor, DDS, PhD, Faculty of Odontology, Malmö University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: December 4, 2020
• First Submitted That Met QC Criteria: December 4, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Postoperative Complications; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban; Dabigatran; Apixaban; Edoxaban; Warfarin
• Other Study ID Numbers: AK-BLD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No