Monotherapy Anticoagulation To Expedite Home Treatment of Venous Thromboembolism (MATHVTE)
Monotherapy Anticoagulation To Expedite Home Treatment of Venous
研究概览
地位
地位
干预/治疗
干预/治疗
研究类型
研究类型
注册 (实际的)
注册
联系人和位置
学习地点
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Indiana
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Indianapolis、Indiana、美国、46202
- Indiana University Health Methodist Hospital
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Indianapolis、Indiana、美国、46202
- Eskenazi Health System
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参与标准
资格标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
Patients must be low risk, as defined by either A or B below:
A. The modified Hestia criteria:
- Systolic blood pressure > 100 mm Hg
- No thrombolysis needed
- No active bleeding
- SaO2 >94% while breathing room air
- Not already anticoagulated
- No more than two doses of IV narcotics in the emergency department
- Other medical or social reasons to admit
- Creatinine clearance >30mL/min
- Not pregnant, severe liver disease or heparin induced thrombocytopenia OR
B. The physician opinion that a patients' overall social and medical situation is favorable for home treatment and the patient has a zero score on the simplified pulmonary embolism severity index (sPESI).
All of the following must true:
- Age < 81 years
- No history of cancer
- No history of heart failure or chronic lung disease
- Pulse < 110 beats/min
- SBP > 99 mm Hg
- O2 sat >89%%
We have chosen either criteria because both have been found equal in terms of safety for outpatient treatment of PE.6,22 Hestia includes implicit questions that most emergency physicians would use as criteria for discharge (e.g., overall medical status and social situation), whereas sPESI does not. For that reason, we have added the additional gestalt assessment question about physician discretion.
- Patients must be discharged in <24 hours after triage in an ED visit with diagnosis of VTE using objective criteria in the emergency department.
Exclusion Criteria:
- VTE diagnosis while taking anticoagulants with evidence of compliance (e.g., physician opinion that patient is taking a Eliquis®, Xarelto® or Pradaxa®, low molecular weight heparin injections or warfarin as prescribed for any condition)
- Sensitivity or contraindication to use of apixaban
- Troponin assay value, drawn as part of usual care and found to be positive, using local standards
- High risk for hemorrhage defined by a score>1.5 using the method of Ruiz Gimenez.3 (Note that several criteria are already excluded by Hestia):
Recent major bleeding, 2 points Creatinine levels >1.2 mg/dl, 1.5 points Anemia, 1.5 points Cancer, 1 point Clinically overt PE, 1 point Age >75 years, 1 point
学习计划
研究是如何设计的?
设计细节
团体/队列数
队列和干预
团体/队列团体/队列 |
干预/治疗干预/治疗 |
|---|---|
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Apixaban for VTE
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Apixaban as standard of care for VTE
|
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Rivaroxaban for VTE
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Rivaroxaban as standard of care for VTE
|
研究衡量的是什么?
主要结果指标
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of re-hospitalization visits for VTE recurrence or bleeding
大体时间:30 days
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Re-hospitalization for > 24 hours due to VTE recurrence or bleeding
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30 days
|
合作者和调查者
合作者
合作者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
学习开始
初级完成 (实际的)
初级完成
研究完成 (实际的)
研究完成
研究注册日期
首次提交
首次提交
首先提交符合 QC 标准的
首先提交符合 QC 标准的
首次发布 (实际的)
首次发布
研究记录更新
最后更新发布 (实际的)
最后更新发布
上次提交的符合 QC 标准的更新
上次提交的符合 QC 标准的更新
最后验证
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
其他研究编号
- CV185-562
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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Apixaban的临床试验
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