此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Alterations of Blood Clotting With the Use of Sequential Compression Devices on the Lower Limbs (TEGLeg)

2013年11月4日 更新者:Guido Fanelli、University of Parma

Effects of Sequential Compression Devices on Coagulation Parameters Assessed by TEG® in Patients Undergoing Major Abdominal Surgery

This study aims to assess possible alteration in coagulation (blood clotting) following treatment with sequential compression devices (SCD) plus low-molecular weight heparin (LMWH) as opposed to LMWH alone.

The investigators will examine coagulation in the early postoperative period of patients undergoing major abdominal surgery during their stay in our Intensive Care Unit.

In addition to common laboratory tests, the investigators will examine coagulation using TEG®, a device which allows a semi-quantitative examination of all phases of coagulation.

研究概览

详细说明

Low molecular weight heparins (LMWH) are routinely used in perioperative prophylaxis of thromboembolic complications [(chiefly deep vein thrombosis (DVT)]. LMWHs have been proved to be safe and equipotent or superior when compared with unfractionated heparin.

Sequential compressing devices (SCD) are relatively novel pneumatic stockings with several air chambers. A computerized pump applies a gradient of pressure which decreases from the foot cranially. Pressure is also applied intermittently according to predetermined schedules. This devices are being employed for DVT prophylaxis in patients for whom anticoagulation therapy is contraindicated, or in those who have a low risk of DVT. They have also been employed to complement anticoagulant therapy in patients at high risk of DVT, such as those undergoing orthopedic surgery (Fordyce, 1992; Handoll, 2002; Warwick, 2002; Pitto, 2004).

The mechanism of action of SCD seems to be primarily mechanical, through a displacement of a column of blood through the venous system and towards the heart; they act as a surrogate of the muscular pump in immobilized patients (Killewich, 1995).

There is also some evidence that SCD activity may influence the coagulation/fibrinolysis system towards hypocoagulability (Dai, 2000; Kohro, 2003); Kohro and colleagues have also hypothesized that the shear forces generated by SCD may alter platelet adhesion by a direct effect on platelets and/or by increasing the release of factors from the venous endothelium (Kohro, 2005).

The investigators aim to assess the effects on coagulation when SCD are applied to patients at high risk of DVT in addition to standard LMWH therapy.The investigators chose to study a population in whom SCD may be useful in reducing the incidence of DVT, such as patients undergoing postoperative monitoring in the intensive care unit (ICU) after major abdominal surgery for cancer.

In addition to standard laboratory tests, the investigators will use thrombelastography (TEG®) to assess all phases of coagulation. A TEG parameter, maximum amplitude (MA), has been linked to an increase of thrombotic complications in a postoperative population (McCrath, 2005).

研究类型

介入性

注册 (实际的)

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

    • PR
      • Parma、PR、意大利、43100
        • University Hospital / Azienda Ospedaliero-Universitaria

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

描述

Inclusion Criteria:

  • Elective major abdominal surgery for neoplasm
  • Planned admission to postsurgical ICU due to the patient's meeting one or more of the following:

    • ASA Physical Status Class 4
    • Surgery of modified Johns-Hopkins class ≥IV
    • ASA 3 with modified Johns-Hopkins class 3 surgery
    • Expected duration of surgery ≥8 h

Exclusion Criteria:

  • History of coagulation abnormalities, either congenital or acquired
  • Ongoing treatment with anticoagulants/antiplatelet agents other than LMWH or hormones
  • Massive edema of the legs
  • Severe peripheral arteriopathy or neuropathy
  • Malformations or recent surgery/trauma to the lower extremities

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:诊断
  • 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:SCD + LMWH
This group will receive sequential compression device therapy to the lower limbs from their ICU admission until the morning after surgery.

Pneumatic stockings will be applied to patients.

Pressures ranging from 12 to 40 mmHg will be applied at different levels of the lower limb for 40-second cycles at 2-minute intervals. Therapy will continue until the morning after surgery.

其他名称:
  • SCD EXPRESS
  • Foot pump
  • 2500 UI qd if ≤ 50 kg body weight
  • 5000 UI qd if > 50 kg
其他名称:
  • 低分子肝素
  • 肝素
  • 抗凝物
  • 分片蛋白
  • 血栓预防

A 2-ml blood sample will be used for each exam. A full analysis will be run both with and without heparinase at each time point.

TEG analyses will be run at:

  • Patient admission (before SCD start)
  • 40-60 min after admission
  • Morning after surgery
其他名称:
  • thrombelastography
  • TEG®
  • thrombelastogram
有源比较器:LMWH only
Patients in this group will receive only standard LMWH therapy during their ICU stay.
  • 2500 UI qd if ≤ 50 kg body weight
  • 5000 UI qd if > 50 kg
其他名称:
  • 低分子肝素
  • 肝素
  • 抗凝物
  • 分片蛋白
  • 血栓预防

A 2-ml blood sample will be used for each exam. A full analysis will be run both with and without heparinase at each time point.

TEG analyses will be run at:

  • Patient admission (before SCD start)
  • 40-60 min after admission
  • Morning after surgery
其他名称:
  • thrombelastography
  • TEG®
  • thrombelastogram

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Reduction in the area under the curve of maximum amplitude (MA) TEG value over time
大体时间:24 hours from application of SCD
24 hours from application of SCD

次要结果测量

结果测量
大体时间
Reduction in the area under the curve of the r time TEG value over time
大体时间:24 h after application of SCD
24 h after application of SCD
Reduction in the area under the curve of the alpha angle TEG value over time
大体时间:24 h after application of SCD
24 h after application of SCD
Incidence of hypotension (mean arterial pressure ≤60 mmHg)
大体时间:≤24 h after application of SCD
≤24 h after application of SCD

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

  • 学习椅:Guido Fanelli, MD、University of Parma
  • 首席研究员:Maria Barbagallo, MD、UO II Anestesia e Rianimazione, Azienda Ospedaliero-Universitaria di Parma

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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

2008年8月1日

初级完成 (实际的)

2010年11月1日

研究完成 (实际的)

2010年11月1日

研究注册日期

首次提交

2008年7月29日

首先提交符合 QC 标准的

2008年7月31日

首次发布 (估计)

2008年8月1日

研究记录更新

最后更新发布 (估计)

2013年11月5日

上次提交的符合 QC 标准的更新

2013年11月4日

最后验证

2013年11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.

订阅