MedTrace Logo

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

NCT00726570 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-11-05

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • University of Parma

    lead OTHER

Principal Investigators

  • Guido Fanelli, MD · University of Parma

  • Maria Barbagallo, MD · UO II Anestesia e Rianimazione, Azienda Ospedaliero-Universitaria di Parma

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00726570 on ClinicalTrials.gov