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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)

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Bayer

Status

Withdrawn

Conditions

Pulmonary Embolism
Venous Thromboembolism
Atrial Fibrillation

Treatments

Other: XAPPORT
Other: Expert Panel ("gold standard")

Study type

Observational

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Full description

Study design: "retrospective/prospective" Observational study

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

NVAF Patients
Description:
Adult female and male patients with non-valvular atrial fibrillation (NVAF) treated with rivaroxaban before and after surgery
Treatment:
Other: Expert Panel ("gold standard")
Other: XAPPORT
VTE/PE Patients
Description:
Adult female and male patients with venous thromboembolism/pulmonary embolism (VTE/PE) treated with rivaroxaban before and after surgery
Treatment:
Other: Expert Panel ("gold standard")
Other: XAPPORT

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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