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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04662515
Other study ID # AK-BLD
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2016
Est. completion date December 31, 2023

Study information

Verified date January 2024
Source Malmö University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 216
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
Type of surgery
surgical or non-surgical extraction one or more teeth
Drug:
Dabigatran

Rivaroxaban

Apixaban

Edoxaban

Warfarin


Locations

Country Name City State
Sweden Skåne University Hospital Helsingborg
Sweden Department of Oral and Maxillofacial Surgery and Oral Medicine, Faculty of Odontology, Malmö University Malmö

Sponsors (2)

Lead Sponsor Collaborator
Malmö University Odontologisk Forskning i Region Skåne (OFRS)

Country where clinical trial is conducted

Sweden, 

Outcome

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