Pulsed Electromagnetic Field Therapy or Pneumatic Compression VTE Prophylaxis

Sponsor
Science Valley Research Institute
Study ID
NCT06958588
Phase
PHASE4
Status
Recruiting
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Conditions

  • Intensive Care Medicine
  • Venous Thromboembolism
  • Venous Thromboembolism (VTE)

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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).

Study Details

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.

Key Dates

First listed
May 6, 2025
Start date
May 25, 2025
Status verified
Mar 2025
Primary completion
Dec 20, 2025
Completion
Mar 20, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Hyperslim
    Pulsed Electromagnetic Field Therapy (PEMF)
  • Active Comparator: Mechanical compression
    Intermittent pneumatic compression ( Covidien Kendall SCD 700®, Cardinal Health or Doctor Life 2600® Venosan)

Primary Outcome Measure

Primary efficacy outcome [ Time Frame: 30 days ]

Central Contacts

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