stop_circleTerminated/Withdrawn

Atrial Fibrillation, Venous Thromboembolism, Pulmonary Embolism

Bayer Identifier:

18903

ClinicalTrials.gov Identifier:

NCT02900404

EudraCT Number:

Not Available

EU CT Number:

Not Available
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 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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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


  • - Patient participated in an interventional drug study within 3 months prior to the surgery and discharge from hospital

Trial summary

Enrollment Goal
0
Trial Dates
February 2017 - March 2017
Phase
Phase 4
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
Many LocationsMany Locations, Germany

Primary Outcome

  • Agreement rate between the recommendations of XAPPORT and the consolidated recommendations of a qualified Expert Panel (“gold standard”).
    date_rangeTime Frame:
    4 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Reasons for discrepancies between the recommendations of XAPPORT and the consolidated recommendations of the qualified Expert Panel (“gold standard”).
    date_rangeTime Frame:
    4 months
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

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