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

November 4, 2013 updated by: 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • PR
      • Parma, PR, Italy, 43100
        • University Hospital / Azienda Ospedaliero-Universitaria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SCD + LMWH
This group will receive sequential compression device therapy to the lower limbs from their ICU admission until the morning after surgery.
Device: Sequential compression device therapy

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.

Other Names:
  • SCD EXPRESS
  • Foot pump
Drug: Dalteparin
  • 2500 UI qd if ≤ 50 kg body weight
  • 5000 UI qd if > 50 kg
Other Names:
  • low molecular weight heparin
  • heparin
  • anticoagulant
  • LMWH
  • Fragmin
  • thromboprophylaxis
Procedure: TEG

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
Other Names:
  • thrombelastography
  • TEG®
  • thrombelastogram
Active Comparator: LMWH only
Patients in this group will receive only standard LMWH therapy during their ICU stay.
Drug: Dalteparin
  • 2500 UI qd if ≤ 50 kg body weight
  • 5000 UI qd if > 50 kg
Other Names:
  • low molecular weight heparin
  • heparin
  • anticoagulant
  • LMWH
  • Fragmin
  • thromboprophylaxis
Procedure: TEG

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
Other Names:
  • thrombelastography
  • TEG®
  • thrombelastogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in the area under the curve of maximum amplitude (MA) TEG value over time
Time Frame: 24 hours from application of SCD
24 hours from application of SCD

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction in the area under the curve of the r time TEG value over time
Time Frame: 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
Time Frame: 24 h after application of SCD
24 h after application of SCD
Incidence of hypotension (mean arterial pressure ≤60 mmHg)
Time Frame: ≤24 h after application of SCD
≤24 h after application of SCD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Parma

Investigators

  • Study Chair: Guido Fanelli, MD, University of Parma
  • Principal Investigator: Maria Barbagallo, MD, UO II Anestesia e Rianimazione, Azienda Ospedaliero-Universitaria di Parma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

July 29, 2008

First Submitted That Met QC Criteria

July 31, 2008

First Posted (Estimate)

August 1, 2008

Study Record Updates

Last Update Posted (Estimate)

November 5, 2013

Last Update Submitted That Met QC Criteria

November 4, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICU-ICU-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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