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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)

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ClinicalTrials.gov Identifier: NCT02900404
Recruitment Status : Withdrawn (due to release of competing App)
First Posted : September 14, 2016
Last Update Posted : May 1, 2017
Sponsor:
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
Change History Complete list of historical versions of study NCT02900404 on ClinicalTrials.gov Archive Site
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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