Pulsed Electromagnetic Field Therapy or Pneumatic Compression VTE Prophylaxis

ConditionsVenous Thromboembolism (VTE)Intensive Care Medicine Venous Thromboembolism

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorScience Valley Research Institute

About this trial

Venous thromboembolism (VTE) is frequent in patients in the intensive care unit (ICU). Pharmacologic prophylaxis is sometimes contraindicated, and mechanical prophylaxis is used. The primary objective of the study is to compare Pulsed Electromagnetic Field Therapy (PEMF) with conventional mechanical prophylaxis for the prevention of VTE in patients in the ICU.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients > 18 years old in ICU

PADUA score> 4 (medical patients) and/or Caprini score> 3 (surgical patients)

Contraindication to pharmacological prophylaxis or indication to combined (pharmacological and mechanical VTE prophylaxis)

Disqualifiers

Patients < 18 years old in ICU

Unable to use mechanical prophylaxis due to trauma, burns, fracture, or problems in inferior members that prevent the use of mechanical prophylaxis

Life expectations less than 24 hours

Trial design

Design model

Parallel

Treatments tested in this trial

Experimental: Hyperslim
Device
The PEMF will be carried out using the Hyperslim® device. The Hyperslim® device is produced by Medical San (Lageado, RS, Brazil).
Active Comparator #1
Device
The intermittent pneumatic compression group will use the devices Covidien Kendall SCD 700® (Cardinal Health) or Doctor Life 2600® (Venosan).

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: HyperslimExperimental treatment 1 intervention

Group B: Mechanical compressionActive comparator 1 intervention

Trial outcomes

Primary outcomes

Primary efficacy outcome

The primary outcome is a composite of symptomatic and asymptomatic VTE (detected by mandatory Doppler ultrasound 24-48 hours after the end of mechanical prophylaxis or PEMF and on day 30 post-randomization) and death due to pulmonary embolism.

Time frame

30 days

Sponsors and contacts

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Science Valley Research Institute

Lead sponsor

Hospital Vera Cruz

Collaborator

Source ClinicalTrials.gov

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