An observational clinical study to assess and assessment of the risk of bleeding after dentoalveolar procedures with Medication with direct oral anticoagulants (DOAKs), antiplatelet agents, and vitamin K antagonists.
- Conditions
- D68.33Z92.1D68.35Personal history of long-term (current) use of anticoagulants
- Registration Number
- DRKS00024889
- Lead Sponsor
- Mund-Kiefer- und Gesichtschirurgische KlinikFAU Uniklinik Erlangen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
Patient is taking DOACs (dabigatran, rivaroxaban, apixaban, or edoxaban), antiplatelet agent, vitamin K antagonist
- Oral surgery procedures include implant placement, tooth extraction, Flapoplasties, osteotomies (more specifically, up to 3 implants and 3 teeth per jaw, osteotomies of teeth (including wisdom teeth), augmentations limited to sinus lift in the upper jaw with one or two implants)
the oral surgery is performed under intubation anesthesia and/or inpatient admission is inpatient admission is necessary preoperatively
- Patient with congenital hemorrhagic diathesis
- Larger augmentations (bone block chin or jaw angle) or if a second second surgical area is necessary for this
- Patients with co-morbidities that preclude local and ambulatory treatment
exclude local and outpatient treatment, the risk of bleeding is assessed as increased
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Postoperative Bleeding risk as a function of anticoagulation and surgical Intervention within the first 10 days postoperatively
- Secondary Outcome Measures
Name Time Method Derivation of risk stratification for anticoagulated patients and postoperative rebleeding.