Atrial FibrillationVeriXAPPORTNCT02900404
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
An observational study of Atrial Fibrillation and Venous Thromboembolism, run by Bayer.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Venous Thromboembolism, Pulmonary Embolism
- What is being tested?
- XAPPORT and Expert Panel ("gold standard")
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2017to 31 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patient participated in an interventional drug study within 3 months prior to the surgery and discharge from hospital
About this study
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
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.
Read the detailed description
Study design: "retrospective/prospective" Observational study
- Being tested
- XAPPORT, Expert Panel ("gold standard")
- Medical subject headings
- Atrial Fibrillation, Venous Thromboembolism, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XAPPORTOther
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")Other
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 group | Role | What they receive |
|---|---|---|
| NVAF Patients | Adult female and male patients with non-valvular atrial fibrillation (NVAF) treated with rivaroxaban before and after surgery Receives: 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 Receives: Other: XAPPORT; Other: Expert Panel ("gold standard") |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement rate between the recommendations of XAPPORT and the consolidated recommendations of a qualified Expert Panel ("gold standard").
Measured: 4 months
Secondary outcomes (1)
Reasons for discrepancies between the recommendations of XAPPORT and the consolidated recommendations of the qualified Expert Panel ("gold standard").
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study start15 Feb 2017 (estimated)
- Primary completion31 Mar 2017 (estimated)
- Study completion31 Mar 2017 (estimated)
Why it stopped: due to release of competing App
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900404
- Sponsor's protocol ID
- 18903
- Acronym
- VeriXAPPORT
- Status last verified
- Apr 2017
- First submitted
- 22 Aug 2016
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02900404
- Acronym / sponsor ID
- VeriXAPPORT / 18903
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: due to release of competing App
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 15 Feb 2017 (estimated)
- Primary completion
- 31 Mar 2017 (estimated)
- Study completion
- 31 Mar 2017 (estimated)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NVAF Patients | – | Other: XAPPORT, Other: Expert Panel ("gold standard")Adult female and male patients with non-valvular atrial fibrillation (NVAF) treated with rivaroxaban before and after surgery |
| VTE/PE Patients | – | Other: XAPPORT, Other: Expert Panel ("gold standard")Adult female and male patients with venous thromboembolism/pulmonary embolism (VTE/PE) treated with rivaroxaban before and after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Patient participated in an interventional drug study within 3 months prior to the surgery and discharge from hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XAPPORTA 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 | NVAF Patients, VTE/PE Patients |
| 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. | Other | NVAF Patients, VTE/PE Patients |
Primary outcome
Agreement rate between the recommendations of XAPPORT and the consolidated recommendations of a qualified Expert Panel ("gold standard").
Time frame: 4 months
1 secondary outcome
Reasons for discrepancies between the recommendations of XAPPORT and the consolidated recommendations of the qualified Expert Panel ("gold standard").
Time frame: 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Venous Thromboembolism, run by Bayer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement rate between the recommendations of XAPPORT and the consolidated recommendations of a qualified Expert Panel ("gold standard"). (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.