Postoperative Complications Clinical Trial
Official title:
Novel Oral Anticoagulants in Oral and Maxillofacial Surgery: Impact on Bleeding Tendency, Surgical Difficulty and Post-operative Complications
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 |
Verified date | January 2024 |
Source | Malmö University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Malmö University | Odontologisk Forskning i Region Skåne (OFRS) |
Sweden,
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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