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• Recruitment Status: Withdrawn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

Tracking Information

• First Submitted Date: August 22, 2016
• First Posted Date: September 14, 2016
• Last Update Posted Date: May 1, 2017
• Estimated Study Start Date: February 15, 2017
• Estimated Primary Completion Date: March 31, 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 9, 2016): Agreement rate between the recommendations of XAPPORT and the consolidated recommendations of a qualified Expert Panel ("gold standard"). [ Time Frame: 4 months ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: September 9, 2016): Reasons for discrepancies between the recommendations of XAPPORT and the consolidated recommendations of the qualified Expert Panel ("gold standard"). [ Time Frame: 4 months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Other
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Atrial Fibrillation
• Venous Thromboembolism
• Pulmonary Embolism

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.
• 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.

Study Groups/Cohorts

• NVAF Patients
  Adult female and male patients with non-valvular atrial fibrillation (NVAF) treated with rivaroxaban before and after surgery
  Interventions:

  • Other: XAPPORT
  • Other: Expert Panel ("gold standard")
• VTE/PE Patients
  Adult female and male patients with venous thromboembolism/pulmonary embolism (VTE/PE) treated with rivaroxaban before and after surgery
  Interventions:

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: March 22, 2017): 0
• Original Estimated Enrollment (submitted: September 9, 2016): 100
• Estimated Study Completion Date: March 31, 2017
• Estimated Primary Completion Date: March 31, 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: Germany

Administrative Information

• NCT Number: NCT02900404
• Other Study ID Numbers: 18903
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Responsible Party: Bayer
• Study Sponsor: Bayer
• Collaborators: Janssen Research & Development, LLC

Investigators

• Study Director: Bayer Study Director; Bayer

• PRS Account: Bayer
• Verification Date: April 2017