Study of a Novel Thrombectomy Device to Treat Acute Iliofemoral Deep Venous Thrombosis
2017年1月15日 更新者：Qianxin Huang、Xuzhou Medical University
Study on the Application of a Novel Aspiration Thrombectomy Device Combined With Catheter-directed Thrombolysis for the Treatment of Acute Iliofemoral Deep Venous Thrombosis
The purpose of this study is to determine whether the novel aspiration thrombectomy device combined with catheter-directed thrombolysis is effective in the treatment of acute iliofemoral deep venous thrombosis (IF-DVT).
研究概览
地位
未知
条件
详细说明
Catheter-directed thrombolysis will be performed in eligible patients with acute IF-DVT.
A combined mechanical thrombectomy will be used to clear the iliac thrombi in experimental group.
The immediate, mid- and long-term outcomes will be recorded.
Quantitative data wiil be expressed as mean ± SD, and will be compared with independent-sample t-test or paired-sample t-test.
Count data will be expressed as a ratio (or percentage), and the chi-square test or the fisher's exact test will be used for comparisons.
A difference with P < 0.05 will be considered statistically significant.
All statistical analyses will be performed using IBM SPSS, version 22.0 (SPSS Inc., Chicago, IL, USA).
研究类型
介入性
注册 (预期的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Jiangsu
-
Xuzhou、Jiangsu、中国、221006
- Department of Interventional Radiology and Vascular Surgery, the Affiliated Hospital of Xuzhou Medical College
-
-
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 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Clinical diagnosis of iliofemoral deep venous thrombosis
- Symptoms of less than 14 days' duration
- With good function status
- A life expectancy of more than 1 year
- A low risk of bleeding
Exclusion Criteria:
- Without iliac vein thrombosis
- Anticoagulation and/or thrombolysis contraindications
- Systemic infection
- Heart, hepatic, renal function insufficiency
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
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Combined thrombectomy device
A manual spiral thrombus broken suction device will be used for thrombectomy before catheter-directed thrombolysis.
Ten million U of urokinase once every 4-6 hours will be used during catheter-directed thrombolysis therapy.
Anticoagulation therapy will be administered via subcutaneous injection of low-molecular-weight heparin calcium (LMWH-Ca 5,000 U/12 h) at discharge
|
A manual spiral thrombus broken suction device will be used for thrombectomy before catheter-directed thrombolysis
catheter-directed thrombolysis will be used in both arms
anticoagulation therapy will be administered via subcutaneous injection of low-molecular-weight heparin calcium (LMWH-Ca 5,000 U/12 h) in both arms at discharge
其他名称：
A total of 100,000 units urokinase once every 4-6 hours will be used during catheter-directed thrombolysis therapy
其他名称：
|
|
其他：Catheter-directed thrombolysis
Participants will undergo catheter-directed thrombolysis alone.
A total of 100,000 units urokinase will be pulse-spray injected through the catheter once every 4-6 h.
Anticoagulation therapy will be administered via subcutaneous injection of low-molecular-weight heparin calcium (LMWH-Ca 5,000 U/12 h) at discharge
|
catheter-directed thrombolysis will be used in both arms
anticoagulation therapy will be administered via subcutaneous injection of low-molecular-weight heparin calcium (LMWH-Ca 5,000 U/12 h) in both arms at discharge
其他名称：
A total of 100,000 units urokinase once every 4-6 hours will be used during catheter-directed thrombolysis therapy
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
patency of lower extremity deep venous
大体时间：up to 36 months
|
participants will be followed for the duration of hospital stay and will be followed for up to 36 months by lower limb vein color Doppler ultrasonography
|
up to 36 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
technical success rate
大体时间：intraoperation
|
The ratio of successful and total number of participants
|
intraoperation
|
|
thrombus removal rate
大体时间：intraoperation
|
The ratio of preoperative and postoperative thrombosis amount
|
intraoperation
|
|
complications
大体时间：intraoperation
|
a composite outcome measure of observation of whether there is evidences of puncture site hematoma, vascular injury or vascular rupture
|
intraoperation
|
|
blood loss
大体时间：intraoperation
|
The volume of blood loss during operation will be recorded
|
intraoperation
|
|
improvement of clinical symptoms and signs
大体时间：up to 36 months
|
participants will be followed for the duration of hospital stay and will be followed for up to 36 months by clinical examinations
|
up to 36 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
incidence of postthrombotic syndrome
大体时间：up to 36 months
|
participants will be followed for up to 36 months to observe the incidence of postthrombotic syndrome which is associated with leg swelling, pain, ulceration
|
up to 36 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。
调查人员
- 研究主任：Qingqiao Zhang, PHD、Xuzhou Medical University
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
2014年12月1日
初级完成 (预期的)
2017年12月1日
研究完成 (预期的)
2017年12月1日
研究注册日期
首次提交
2015年3月25日
首先提交符合 QC 标准的
2015年4月7日
首次发布 (估计)
2015年4月13日
研究记录更新
最后更新发布 (估计)
2017年1月18日
上次提交的符合 QC 标准的更新
2017年1月15日
最后验证
2017年1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.