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临床试验/NCT00726570
NCT00726570终止不适用

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

University of Parma1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2008年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
40
试验地点
1
主要终点
Reduction in the area under the curve of maximum amplitude (MA) TEG value over time

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

SCD + LMWH

Experimental

This group will receive sequential compression device therapy to the lower limbs from their ICU admission until the morning after surgery.

干预措施: TEG (Procedure)

LMWH only

Active Comparator

Patients in this group will receive only standard LMWH therapy during their ICU stay.

干预措施: TEG (Procedure)

SCD + LMWH

Experimental

This group will receive sequential compression device therapy to the lower limbs from their ICU admission until the morning after surgery.

干预措施: Sequential compression device therapy (Device)

LMWH only

Active Comparator

Patients in this group will receive only standard LMWH therapy during their ICU stay.

干预措施: Dalteparin (Drug)

SCD + LMWH

Experimental

This group will receive sequential compression device therapy to the lower limbs from their ICU admission until the morning after surgery.

干预措施: Dalteparin (Drug)

结局指标

主要结局

Reduction in the area under the curve of maximum amplitude (MA) TEG value over time

时间窗: 24 hours from application of SCD

次要结局

  • Reduction in the area under the curve of the alpha angle TEG value over time(24 h after application of SCD)
  • Reduction in the area under the curve of the r time TEG value over time(24 h after application of SCD)
  • Incidence of hypotension (mean arterial pressure ≤60 mmHg)(≤24 h after application of SCD)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guido Fanelli

MD

University of Parma

研究点 (1)

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