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Withdrawn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
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Sponsor:
Bayer
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer
Tracking Information | |||||
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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 |
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 |
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 |
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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. | ||||
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Intervention |
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Withdrawn | ||||
Actual Enrollment |
0 | ||||
Original Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | Bayer | ||||
Study Sponsor | Bayer | ||||
Collaborators | Janssen Research & Development, LLC | ||||
Investigators |
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PRS Account | Bayer | ||||
Verification Date | April 2017 |