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Intermittent Pneumatic Compression in Surgical Patients at Extremely-high Risk for Venous Thromboembolism

NCT03044574 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 407

Last updated 2021-02-04

Study results available
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Summary

The aim of the study is to evaluate efficacy and safety of venous thromboembolism prophylaxis by the combination of graduated compression stockings (GCS), standard doses of low-molecular-weight heparins (LMWH) and sequential compression device (SCD) in the mixed group of surgical patients at high and extremely high risk for venous thromboembolism.

Conditions

  • Venous Thromboembolism
  • Venous Thrombosis

Interventions

DEVICE

SCD

Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge.

DEVICE

GCS

Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge

DRUG

LMWH

LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Pirogov Russian National Research Medical University

    lead OTHER

Principal Investigators

  • Kirill Lobastov, PhD · Pirogov Russian National Research Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2018-09-30
Completion
2018-12-31
FDA Device
Yes

Countries

  • Russia

Study Locations

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Companies

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 NCT03044574 on ClinicalTrials.gov