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due to release of competing App
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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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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.
Study design: "retrospective/prospective" Observational study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVAF Patients | Adult female and male patients with non-valvular atrial fibrillation (NVAF) treated with rivaroxaban before and after surgery |
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| VTE/PE Patients | Adult female and male patients with venous thromboembolism/pulmonary embolism (VTE/PE) treated with rivaroxaban before and after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XAPPORT | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Agreement rate between the recommendations of XAPPORT and the consolidated recommendations of a qualified Expert Panel ("gold standard"). | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reasons for discrepancies between the recommendations of XAPPORT and the consolidated recommendations of the qualified Expert Panel ("gold standard"). | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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At least 100 evaluable female or male inpatients shall be enrolled after having been discharged from hospital and provide data for analyses. Patients meeting all inclusion criteria and no exclusion criterion are suitable for this study. Enrolment will continue until at least 100 patients with complete data for analysis are available (i.e. 100 evaluable patients). An adequate representation of every bleeding and thromboembolism risk category per indication in the matrix will be taken into account.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
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| Expert Panel ("gold standard") | Other | 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. |
|
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D054556 | Venous Thromboembolism |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
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