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Measurement of D-Dimer Levels in Patients With Confirmed Deep Vein Thrombosis

2015年6月2日 更新者:Diagnostica Stago
Measurement of D-Di (D-Dimer) levels using the in-vitro diagnostic reagent STA® - Liatest® D-Di and STA® - Liatest® D-Di PLUS in plasma samples from patients diagnosed with Deep Vein Thrombosis (DVT) Data from this study may be used in conjunction with data from the prospective study entitled "STA® - Liatest® D-Di - Exclusion of Venous Thromboembolism (VTE)", NCT01221805, the DiET study,

研究概览

地位

终止

研究类型

观察性的

注册 (实际的)

6

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

    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73104
        • The University of Oklahoma Health Sciences Center

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

不超过 80年 (孩子、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

概率样本

研究人群

Patients with proximal DVT diagnosed by imaging technique and with a low and moderate Wells score

描述

Inclusion Criteria:

  • The study population tested will be recruited from ambulatory outpatients (presenting at the emergency unit or outpatient clinic) suspected of having DVT.
  • Patient is < 80 years old.
  • Patient presenting at least one of these symptoms indicative of proximal DVT: leg pain, tenderness (discomfort through palpation), leg swelling and /or edema,
  • Patient has confirmed proximal DVT by imaging
  • Low or moderate Wells score
  • Patient provides written informed consent to participate in the sample collection

Exclusion Criteria:

  • Patient presenting with a condition that may be associated with increased D-dimer levels, even in the absence of VTE, such as:

    1. Fibrinolytic therapy within the previous seven (7) days,
    2. Bone fracture or surgery (with general anesthesia longer than thirty (30) minutes) within the previous one (1) month,
    3. Deep hematoma diagnosed by imaging techniques within the previous one (1) month,
    4. Disseminated malignancies and active cancer (active cancer defined as: cancer for which therapeutic or palliative treatment is either ongoing at the time of enrolment or has stopped less than six (6) months before enrolment),
    5. Sepsis, severe infections, pneumonia within the previous 1 month,
    6. Known liver cirrhosis,
    7. Pregnancy or post-partum within the previous 1 month,
    8. Atherosclerotic vascular disease thrombosis within the previous 1month (e.g. myocardial infarction, stroke, coronary syndrome, peripheral artery disease stage III or IV),
    9. Sickle cell disease,
  • Patients presenting with a suspect thrombotic event related to catheter implantation
  • Ongoing therapeutic anticoagulants (curative and preventive treatment) starting twenty four (24) hours or more before the blood drawing for D-dimer testing

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

队列和干预

团体/队列
Deep Venous Thrombosis (DVT)
DVT diagnosed by imaging technique with a low or moderate Wells score

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
STA Liatest DDi results in DVT positive cases
大体时间:At the initial visit (up to 24 hours)
Prospective, ambulatory outpatients (presenting to the emergency unit or outpatient clinic) suspected of having DVT, with a proximal positive imaging results, will be screened for eligibility using the inclusion and exclusion criteria (see Section above). Then the eligible patients will be evaluated using the Wells score and only patient with Low or moderate Pre-Test Probability (PTP) will receive full explanation concerning nature, objectives and risks associated to the participation in this study. Written informed consent will be obtained from each participating subject prior blood drawing, processing, plasma aliquoting and freezing at -80°C for D-Dimer testing (STA Liatest DDi). The whole process, starting from the moment the patient is diagnosed with DVT, should not exceed 24 hours.
At the initial visit (up to 24 hours)

次要结果测量

结果测量
措施说明
大体时间
STA Liatest DDi Versus STA Liatest DDi Plus
大体时间:At the initial visit (up to 24 hours)
Prospective, ambulatory outpatients (presenting to the emergency unit or outpatient clinic) suspected of having DVT, with a proximal positive imaging results, will be screened for eligibility using the inclusion and exclusion criteria (see Section above). Then the eligible patients will be evaluated using the Wells score and only patient with Low or moderate PTP will receive full explanation concerning nature, objectives and risks associated to the participation in this study. Written informed consent will be obtained from each participating subject prior blood drawing, processing, plasma aliquoting and freezing at -80°C for D-Dimer testing (STA Liatest DDi Plus). The whole process, starting from the moment the patient is diagnosed with DVT, should not exceed 24 hours
At the initial visit (up to 24 hours)

其他结果措施

结果测量
措施说明
大体时间
Plasma bank for DDi measurements
大体时间:At the initial visit (up to 24 hours)
Prospective, ambulatory outpatients (presenting to the emergency unit or outpatient clinic) suspected of having DVT, with a proximal positive imaging results, will be screened for eligibility using the inclusion and exclusion criteria (see Section above). Then the eligible patients will be evaluated using the Wells score and only patient with Low or moderate PTP will receive full explanation concerning nature, objectives and risks associated to the participation in this study. Written informed consent will be obtained from each participating subject prior blood drawing, processing, plasma aliquoting and freezing at -80°C for D-Dimer testing (STA Liatest DDi or STA Liatest DDi Plus to investigate unmatched results). The whole process, starting from the moment the patient is diagnosed with DVT, should not exceed 24 hours
At the initial visit (up to 24 hours)

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

  • 首席研究员:Suman Wasan Rathbun, MD、University of Oklahoma Health Sciences

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4月1日

初级完成 (实际的)

2015年1月1日

研究完成 (实际的)

2015年1月1日

研究注册日期

首次提交

2014年2月26日

首先提交符合 QC 标准的

2014年3月4日

首次发布 (估计)

2014年3月5日

研究记录更新

最后更新发布 (估计)

2015年6月3日

上次提交的符合 QC 标准的更新

2015年6月2日

最后验证

2015年6月1日

更多信息

与本研究相关的术语

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.

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