Trial | NCT04662515  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Observational

  • Status

    Recruiting

  • Study Participants

    300
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.
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 Started
Jun 01
2016
Primary Completion
Dec 31
2026
Anticipated
Study Completion
Dec 31
2026
Anticipated
Last Update
Oct 23
2023

Procedure Type of surgery

surgical or non-surgical extraction one or more teeth

Drug Dabigatran

Drug Apixaban

Drug Edoxaban

Drug Warfarin

DOAC None

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

Warfarin None

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

No blood thinners None

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.

Criteria 

Inclusion Criteria:

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

warfarin or
DOACs or
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
No Results Posted