Postoperative Complications Clinical Trial
— TEGLegOfficial title:
Effects of Sequential Compression Devices on Coagulation Parameters Assessed by TEG® in Patients Undergoing Major Abdominal Surgery
Verified date | November 2013 |
Source | University of Parma |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 40 |
Est. completion date | November 2010 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Italy | University Hospital / Azienda Ospedaliero-Universitaria | Parma | PR |
Lead Sponsor | Collaborator |
---|---|
University of Parma |
Italy,
Dai G, Tsukurov O, Orkin RW, Abbott WM, Kamm RD, Gertler JP. An in vitro cell culture system to study the influence of external pneumatic compression on endothelial function. J Vasc Surg. 2000 Nov;32(5):977-87. — View Citation
Fordyce MJ, Ling RS. A venous foot pump reduces thrombosis after total hip replacement. J Bone Joint Surg Br. 1992 Jan;74(1):45-9. — View Citation
Handoll HH, Farrar MJ, McBirnie J, Tytherleigh-Strong G, Milne AA, Gillespie WJ. Heparin, low molecular weight heparin and physical methods for preventing deep vein thrombosis and pulmonary embolism following surgery for hip fractures. Cochrane Database Syst Rev. 2002;(4):CD000305. Review. — View Citation
Killewich LA, Sandager GP, Nguyen AH, Lilly MP, Flinn WR. Venous hemodynamics during impulse foot pumping. J Vasc Surg. 1995 Nov;22(5):598-605. Erratum in: J Vasc Surg 1996 Feb;23(2):240. — View Citation
Kohro S, Yamakage M, Sato K, Sato JI, Namiki A. Intermittent pneumatic foot compression can activate blood fibrinolysis without changes in blood coagulability and platelet activation. Acta Anaesthesiol Scand. 2005 May;49(5):660-4. — View Citation
Kohro S, Yamakage M, Takahashi T, Ota K, Kondo M, Namiki A. Effects of intermittent pneumatic foot compression on blood coagulability and fibrinolysis assessed by a whole blood viscometer Sonoclot. J Anesth. 2003;17(3):208-10. — View Citation
McCrath DJ, Cerboni E, Frumento RJ, Hirsh AL, Bennett-Guerrero E. Thromboelastography maximum amplitude predicts postoperative thrombotic complications including myocardial infarction. Anesth Analg. 2005 Jun;100(6):1576-83. — View Citation
Pitto RP, Hamer H, Heiss-Dunlop W, Kuehle J. Mechanical prophylaxis of deep-vein thrombosis after total hip replacement a randomised clinical trial. J Bone Joint Surg Br. 2004 Jul;86(5):639-42. — View Citation
Warwick D, Harrison J, Whitehouse S, Mitchelmore A, Thornton M. A randomised comparison of a foot pump and low-molecular-weight heparin in the prevention of deep-vein thrombosis after total knee replacement. J Bone Joint Surg Br. 2002 Apr;84(3):344-50. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in the area under the curve of maximum amplitude (MA) TEG value over time | 24 hours from application of SCD | No | |
Secondary | Reduction in the area under the curve of the r time TEG value over time | 24 h after application of SCD | No | |
Secondary | Reduction in the area under the curve of the alpha angle TEG value over time | 24 h after application of SCD | No | |
Secondary | Incidence of hypotension (mean arterial pressure =60 mmHg) | =24 h after application of SCD | No |
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