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

Study Overview
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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.

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.

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

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

Intervention / Treatment
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* Procedure: Type of surgery
* Drug: Dabigatran
* Drug: Rivaroxaban
* Drug: Apixaban
* Drug: Edoxaban
* Drug: Warfarin


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DOAC<br>Information about which type of DOAC and the dose that is prescribed to the patient will be collected. | Procedure: Type of surgery<br>* surgical or non-surgical extraction one or more teeth<br>Drug: Dabigatran<br> <br> Drug: Rivaroxaban<br> <br> Drug: Apixaban<br> <br> Drug: Edoxaban<br> <br> |
| Warfarin<br>A PK-INR ≤3.0 retained whitin the last 24 hours have to be present for inclusion. | Procedure: Type of surgery<br>* surgical or non-surgical extraction one or more teeth<br>Drug: Warfarin<br> <br> |
| No blood thinners<br> | Procedure: Type of surgery<br>* surgical or non-surgical extraction one or more teeth<br>|

What is the study measuring?
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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 |