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

Atrial Fibrillation Clinical Trial

— VeriXAPPORT  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02900404
• Other study ID #: 18903
• Status: Withdrawn
• Phase: N/A
• First received: August 22, 2016
• Last updated: April 28, 2017
• Start date: February 15, 2017
• Est. completion date: March 31, 2017

Study information

• Verified date: April 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Study design: "retrospective/prospective" Observational study

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Embolism
• Pulmonary Embolism
• Thromboembolism
• Venous Thromboembolism

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement rate between the recommendations of XAPPORT and the consolidated recommendations of a qualified Expert Panel ("gold standard").		4 months
Secondary	Reasons for discrepancies between the recommendations of XAPPORT and the consolidated recommendations of the qualified Expert Panel ("gold standard").		4 months

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