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)
2017年4月28日 更新者：Bayer
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.
研究概览
详细说明
Study design: "retrospective/prospective" Observational study
研究类型
观察性的
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
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.
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：其他
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
NVAF Patients
Adult female and male patients with non-valvular atrial fibrillation (NVAF) treated with rivaroxaban before and after surgery
|
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.
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
|
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.
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Agreement rate between the recommendations of XAPPORT and the consolidated recommendations of a qualified Expert Panel ("gold standard").
大体时间：4 months
|
4 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Reasons for discrepancies between the recommendations of XAPPORT and the consolidated recommendations of the qualified Expert Panel ("gold standard").
大体时间：4 months
|
4 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2017年2月15日
初级完成 (预期的)
2017年3月31日
研究完成 (预期的)
2017年3月31日
研究注册日期
首次提交
2016年8月22日
首先提交符合 QC 标准的
2016年9月9日
首次发布 (估计)
2016年9月14日
研究记录更新
最后更新发布 (实际的)
2017年5月1日
上次提交的符合 QC 标准的更新
2017年4月28日
最后验证
2017年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.