Postoperative Complications Clinical Trial
Official title:
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.
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).
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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