Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (due to release of competing App)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

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

Layout table for study information
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

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

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.




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900404


Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Investigators
Layout table for investigator information
Study Director: Bayer Study Director Bayer

Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02900404     History of Changes
Other Study ID Numbers: 18903
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for 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