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

NCT00726570 | Terminated

• 1 other identifier: ICU-ICU-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coagulation, Blood; Compression Devices, Intermittent Pneumatic; Postoperative Complications; Thrombelastography

Keywords

Disorders, Blood coagulation; Deep Vein Thrombosis; Perioperative Care; Digestive System Surgical Procedures

Outcome Measures

Primary Outcomes (1)

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

  24 hours from application of SCD

Secondary Outcomes (3)

• Reduction in the area under the curve of the r time TEG value over time

  24 h after application of SCD

• Reduction in the area under the curve of the alpha angle TEG value over time

  24 h after application of SCD

• Incidence of hypotension (mean arterial pressure ≤60 mmHg)

  ≤24 h after application of SCD

Study Arms (2)

SCD + LMWH

EXPERIMENTAL

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; Drug: Dalteparin; Procedure: TEG

LMWH only

ACTIVE COMPARATOR

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

Drug: Dalteparin; Procedure: TEG

Interventions

Sequential compression device therapy DEVICE

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.

Also known as: SCD EXPRESS, Foot pump

SCD + LMWH

Dalteparin DRUG

* 2500 UI qd if ≤ 50 kg body weight * 5000 UI qd if \> 50 kg

Also known as: low molecular weight heparin, Fragmin, heparin, thromboprophylaxis, anticoagulant, LMWH

LMWH only; SCD + LMWH

TEG PROCEDURE

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

Also known as: thrombelastography, TEG®, thrombelastogram

LMWH only; SCD + LMWH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Parma: lead

Study Sites (1)

University Hospital / Azienda Ospedaliero-Universitaria

Parma, PR, 43100, Italy

Location

Related Publications (9)

• 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. doi: 10.1302/0301-620X.74B1.1732264.

  PMID: 1732264 BACKGROUND

• 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. doi: 10.1002/14651858.CD000305.

  PMID: 12519540 BACKGROUND

• 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. doi: 10.1302/0301-620x.84b3.12372.

  PMID: 12002490 BACKGROUND

• 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. doi: 10.1302/0301-620x.86b5.14763.

  PMID: 15274256 BACKGROUND

• 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. doi: 10.1016/s0741-5214(95)70046-3.

  PMID: 7494362 BACKGROUND

• 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. doi: 10.1067/mva.2000.110357.

  PMID: 11054230 BACKGROUND

• 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. doi: 10.1007/s00540-003-0180-x. No abstract available.

  PMID: 12911214 BACKGROUND

• 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. doi: 10.1111/j.1399-6576.2005.00661.x.

  PMID: 15836680 BACKGROUND

• 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):1576-1583. doi: 10.1213/01.ANE.0000155290.86795.12.

  PMID: 15920177 BACKGROUND

MeSH Terms

Conditions

Thrombosis; Postoperative Complications; Blood Coagulation Disorders; Venous Thrombosis

Interventions

Dalteparin; Heparin, Low-Molecular-Weight; Heparin; Anticoagulants; Thrombelastography

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Guido Fanelli, MD

  University of Parma

  STUDY CHAIR

• Maria Barbagallo, MD

  UO II Anestesia e Rianimazione, Azienda Ospedaliero-Universitaria di Parma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 29, 2008
• First Posted: August 1, 2008
• Study Start: August 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: November 5, 2013

Record last verified: 2013-11

Locations

IT (1)