Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00726570
Other study ID # ICU-ICU-01
Secondary ID
Status Terminated
Phase N/A
First received July 29, 2008
Last updated November 4, 2013
Start date August 2008
Est. completion date November 2010

Study information

Verified date November 2013
Source University of Parma
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

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.
Drug:
Dalteparin
2500 UI qd if = 50 kg body weight 5000 UI qd if > 50 kg
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

Locations

Country Name City State
Italy University Hospital / Azienda Ospedaliero-Universitaria Parma PR

Sponsors (1)

Lead Sponsor Collaborator
University of Parma

Country where clinical trial is conducted

Italy, 

References & Publications (9)

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

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT03181620 - Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation N/A
Recruiting NCT04205058 - Coffee After Pancreatic Surgery N/A
Completed NCT06425601 - A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy N/A
Completed NCT02565420 - Saline Versus Lactated Ringer's Solution: The SOLAR Fluid Trial N/A
Recruiting NCT04519593 - ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma N/A
Completed NCT03662672 - Rib Raising for Post-operative Ileus N/A
Completed NCT03787849 - Epigenetics in PostOperative Pediatric Emergence Delirium N/A
Active, not recruiting NCT05886387 - a Bayesian Analysis of Three Randomised Clinical Trials of Intraoperative Ventilation
Not yet recruiting NCT06351475 - Efficacy of Intraoperative Use of 20% Albumin Combined With Ringer Lactate Versus Ringer Lactate During Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy N/A
Not yet recruiting NCT05052021 - The South African Coronavirus Disease of 2019 (COVID-19) Surgical Outcomes Study
Not yet recruiting NCT03591432 - A Trial Comparing Transnasal humidified Rapid insufflation Ventilatory Exchange (THRIVE) and Apneic Oxygenation With Facemask Ventilation in Elderly Patients Undergoing Induction of Anaesthesia. N/A
Not yet recruiting NCT03639012 - Outcomes of Carbohydrate Loading Paediatric Patients Preoperatively for Tonsillectomy and Adenoidectomy N/A
Not yet recruiting NCT03275324 - Use of Integrated Pulmonary Index to Predict Post-Operative Respiratory Adverse Events in High Risk Patients N/A
Recruiting NCT02763878 - Uncut Roux-en-y Anastomosis Reduce Postoperative Complication and Improve Nutritional Status After Distal Gastrectomy Phase 3
Completed NCT02891187 - Visits Versus Telephone Calls for Postoperative Care N/A
Completed NCT02947789 - Predictive Model for Postoperative Mortality N/A
Not yet recruiting NCT02542423 - Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure. N/A
Completed NCT02766062 - Effects of Propofol and Sevoflurane on Early POCD in Elderly Patients With Metabolic Syndrome N/A
Recruiting NCT01934049 - Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty Phase 4
Enrolling by invitation NCT01744938 - Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice Phase 3