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

This study has been terminated.
(Failed to reach the expected enrollment rates by the end of 2010)
Sponsor:
Information provided by (Responsible Party):
Guido Fanelli, University of Parma
ClinicalTrials.gov Identifier:
NCT00726570
First received: July 29, 2008
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Coagulation, Blood
Compression Devices, Intermittent Pneumatic
Postoperative Complications
Thrombelastography
Device: Sequential compression device therapy
Drug: Dalteparin
Procedure: TEG

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Effects of Sequential Compression Devices on Coagulation Parameters Assessed by TEG® in Patients Undergoing Major Abdominal Surgery

Resource links provided by NLM:


Further study details as provided by University of Parma:

Primary Outcome Measures:
  • Reduction in the area under the curve of maximum amplitude (MA) TEG value over time [ Time Frame: 24 hours from application of SCD ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in the area under the curve of the r time TEG value over time [ Time Frame: 24 h after application of SCD ] [ Designated as safety issue: No ]
  • Reduction in the area under the curve of the alpha angle TEG value over time [ Time Frame: 24 h after application of SCD ] [ Designated as safety issue: No ]
  • Incidence of hypotension (mean arterial pressure ≤60 mmHg) [ Time Frame: ≤24 h after application of SCD ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: August 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • Fragmin
  • heparin
  • thromboprophylaxis
  • anticoagulant
  • LMWH
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
  • Fragmin
  • heparin
  • thromboprophylaxis
  • anticoagulant
  • LMWH
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726570

Locations
Italy
University Hospital / Azienda Ospedaliero-Universitaria
Parma, PR, Italy, 43100
Sponsors and Collaborators
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
  More Information

Publications:

Responsible Party: Guido Fanelli, MD, University of Parma
ClinicalTrials.gov Identifier: NCT00726570     History of Changes
Other Study ID Numbers: ICU-ICU-01
Study First Received: July 29, 2008
Last Updated: November 4, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University of Parma:
Disorders, Blood coagulation
Deep Vein Thrombosis
Perioperative Care
Digestive System Surgical Procedures

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes
Anticoagulants
Heparin, Low-Molecular-Weight
Dalteparin
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 28, 2014