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)

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

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 Overview

• Status: Withdrawn
• Conditions: Atrial Fibrillation; Venous Thromboembolism; Pulmonary Embolism
• Intervention / Treatment: Other: XAPPORT; Other: Expert Panel ("gold standard")

Detailed Description

Study design: "retrospective/prospective" Observational study

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Janssen Research & Development, LLC
• Investigators: Study Director: Bayer Study Director, Bayer

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2017
• Primary Completion (Estimated): March 31, 2017
• Study Completion (Estimated): March 31, 2017

Study Registration Dates

• First Submitted: August 22, 2016
• First Submitted That Met QC Criteria: September 9, 2016
• First Posted (Estimated): September 14, 2016

Study Record Updates

• Last Update Posted (Actual): November 13, 2024
• Last Update Submitted That Met QC Criteria: November 11, 2024
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Respiratory Tract Diseases; Arrhythmias, Cardiac; Lung Diseases; Embolism and Thrombosis; Pulmonary Embolism; Atrial Fibrillation; Embolism; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: 18903

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No