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)

• ClinicalTrials.gov Identifier: NCT02900404
• Recruitment Status: Withdrawn
• First Posted: September 14, 2016
• Last Update Posted: May 1, 2017
• Sponsor: Bayer
• Collaborator: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Bayer

Study Description

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.

Condition or disease	Intervention/treatment
Atrial Fibrillation; Venous Thromboembolism; Pulmonary Embolism	Other: XAPPORT; Other: Expert Panel ("gold standard")

Detailed Description:

Study design: "retrospective/prospective" Observational study

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: 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
• Estimated Study Start Date: February 15, 2017
• Estimated Primary Completion Date: March 31, 2017
• Estimated Study Completion Date: March 31, 2017

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. Agreement rate between the recommendations of XAPPORT and the consolidated recommendations of a qualified Expert Panel ("gold standard"). [ Time Frame: 4 months ]

Secondary Outcome Measures :

1. Reasons for discrepancies between the recommendations of XAPPORT and the consolidated recommendations of the qualified Expert Panel ("gold standard"). [ Time Frame: 4 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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.

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Bayer

Janssen Research & Development, LLC

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT02900404 History of Changes
• Other Study ID Numbers: 18903
• First Posted: September 14, 2016
• Last Update Posted: May 1, 2017
• Last Verified: April 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pulmonary Embolism; Atrial Fibrillation; Thromboembolism; Embolism; Venous Thromboembolism; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Embolism and Thrombosis; Vascular Diseases; Lung Diseases; Respiratory Tract Diseases; Rivaroxaban; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anticoagulants