Trial Condition(s):
Atrial Fibrillation, Pulmonary Embolism
Verification of XAPPORT: a decision support app for physicians used for patients anticoagulated with rivaroxaban in terms of anticoagulation Management in elective surgery: verification process of medical decision algorithm (VeriXAPPORT)
Bayer Identifier:
18903
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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 entryExclusion Criteria
- Patient participated in an interventional drug study within 3 months prior to the surgery and discharge from hospital
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations |
|---|
Trial Design
VeriXAPPORT: Verification of XAPPORT: a decision support app for physicians used for patients anticoagulated with rivaroxaban in terms of anticoagulation management in elective surgery: verification process of medical decision algorithm
Trial Type:
Observational
Intervention Type:
Other
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- Agreement rate between the recommendations of XAPPORT and the consolidated recommendations of a qualified Expert Panel (“gold standard”).Timeframe: 4 months
Secondary Outcome
- Reasons for discrepancies between the recommendations of XAPPORT and the consolidated recommendations of the qualified Expert Panel (“gold standard”).Timeframe: 4 months
Additional Information
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