Atrial Fibrillation, Pulmonary Embolism, Venous Thromboembolism
Conditions
Brief summary
This study shall determine whether XAPPORT - a mobile device app based on different guidelines, the summary of product characteristics of rivaroxaban, and clinical facts and practice - provides adequate guidance to physicians attending patients undergoing elective surgery, who have to interrupt treatment with rivaroxaban for surgery, in deciding how to approach the pre- and postoperative management of anticoagulation.
Detailed description
Study design: retrospective/prospective Observational study
Interventions
OTHERXAPPORT
A mobile device app based on different guidelines provides adequate guidance to physicians attending patients undergoing elective surgery, who have to interrupt treatment with rivaroxaban for surgery, in deciding how to approach the pre- and postoperative management of anticoagulation.
OTHERExpert Panel (gold standard)
A national panel of experts comprising anesthetists and surgeons from various disciplines advised in developing an algorithm supporting physicians how to approach the perioperative management of anticoagulation in patients receiving rivaroxaban and requiring elective surgery.
Sponsors
Janssen Research & Development, LLC
Bayer
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female or male patient ≥18 years who provided signed and dated informed consent to the use of their medical data * Patient was treated with rivaroxaban before and after surgery because of non-valvular atrial fibrillation (NVAF) or venous thromboembolism/pulmonary embolism (VTE/PE) * Elective surgery in a department of General Surgery or Orthopedics / Trauma Surgery was performed within the last 12 months before study start * The patient has been discharged from hospital * Patient's medical records are available for data entry
Exclusion criteria
* Patient participated in an interventional drug study within 3 months prior to the surgery and discharge from hospital
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Agreement rate between the recommendations of XAPPORT and the consolidated recommendations of a qualified Expert Panel (gold standard). | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Reasons for discrepancies between the recommendations of XAPPORT and the consolidated recommendations of the qualified Expert Panel (gold standard). | 4 months |
Outcome results
None listed