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

Withdrawn

• Conditions: Atrial Fibrillation; Venous Thromboembolism; Pulmonary Embolism
• Interventions: Other: XAPPORT; Other: Expert Panel ("gold standard")

• Registration Number: NCT02900404
• Lead Sponsor: Bayer

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

Study Timeline

• Study First Submitted: 2016-08-22
• Study First Submitted QC: 2016-09-09
• Study First Posted: 2016-09-14
• Study Start: 2017-02-15
• Primary Completion: 2017-03-31
• Study Completion: 2017-03-31
• Status Verified: 2017-04
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Agreement rate between the recommendations of XAPPORT and the consolidated recommendations of a qualified Expert Panel ("gold standard").	4 months

Secondary Outcome Measures

Name	Time	Method
Reasons for discrepancies between the recommendations of XAPPORT and the consolidated recommendations of the qualified Expert Panel ("gold standard").	4 months