Mechanical methods for thrombosis prophylaxis.
Joseph A Caprini
https://pubmed.ncbi.nlm.nih.gov/19850588Actively Recruiting
Phase 4
All Genders
ID06958588
Pulsed Electromagnetic Field Therapy Compared to Mechanical Compression for VTE Prevention in ICU Patients
Led by Science Valley Research Institute · Updated on 2025-05-06
50
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
S
Science Valley Research Institute
Lead Sponsor
H
Hospital Vera Cruz
Collaborating Sponsor
AI-Summary
What this Trial Is About
Venous thromboembolism (VTE) is common in patients admitted to the intensive care unit (ICU), where some cannot receive pharmacological prevention due to contraindications. This study compares Pulsed Electromagnetic Field Therapy (PEMF) with conventional mechanical prophylaxis for preventing VTE in ICU patients. The trial is a prospective, randomized, open-label, active-controlled study conducted at two hospitals in Brazil, focusing on patients with high VTE risk scores and specific prophylaxis needs. Participants will be randomly assigned to receive either PEMF using the Hyperslim ae device or intermittent pneumatic compression with devices such as Covidien Kendall SCD 700 ae or Doctor Life 2600 ae. The PEMF treatment involves placing device pads on the lower limbs for 30 minutes, three times daily, while the pneumatic compression devices are applied full-time on the lower limbs during the ICU stay. Trained physiotherapists and nurses will place and monitor the devices according to institutional protocols. During the study, patients will be monitored continuously for signs of VTE, lab changes, and any local adverse effects like skin lesions or edema. Patients able to respond will rate device tolerability. VTE events will be assessed at ICU discharge and 30 days after randomization using Doppler ultrasound. The main outcome measures include the combined symptomatic and asymptomatic VTE rates at 30 days, major bleeding incidents, and device-related adverse events, with safety and efficacy analyzed statistically.
CONDITIONS
Brief Title
Pulsed Electromagnetic Field Therapy or Pneumatic Compression VTE Prophylaxis
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Patients older than 18 years in the ICU
- PADUA score greater than 4 for medical patients and/or Caprini score greater than 3 for surgical patients
- Contraindication to pharmacological prophylaxis or indication for combined pharmacological and mechanical VTE prophylaxis
You will not qualify if you...
- Patients younger than 18 years in the ICU
- Unable to use mechanical prophylaxis due to trauma, burns, fractures, or problems in lower limbs
- Life expectancy less than 24 hours
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Treatment
Duration - Duration of ICU stay
Participants receive either pulsed electromagnetic field therapy using the Hyperslim® device applied to the lower limbs for 30 minutes thrice daily, or intermittent pneumatic compression devices placed on the lower limbs and used continuously while in the ICU. The critical care team monitors patients 24 hours/day for signs of VTE and device-related adverse effects.
Continuous monitoring while in ICU with daily assessments
Follow-up
Duration - Up to 30 days post-randomization
After mechanical prophylaxis ends, participants are evaluated for thromboembolic events including Doppler ultrasound of the lower limbs at ICU discharge and again at 30 days post-randomization.
2 visits: at ICU discharge and at 30 days post-randomization
Trial Site Locations
Total: 1 location
1
Hospital Vera Cruz, Belo Horizonte, MG, Brazil
Belo Horizonte, BH, Brazil, 30190-130
Actively Recruiting
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Research Team
E
Eduardo Fonseca Sad, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NA
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Prevention and management of venous thromboembolism. International Consensus Statement. Guidelines according to scientific evidence.
Andrew N Nicolaides, Jawed Fareed, Alex C Spyropoulos...
https://pubmed.ncbi.nlm.nih.gov/38421381European guidelines on peri-operative venous thromboembolism prophylaxis: first update.: Chapter 4: Prophylaxis in critical care patients.
Fanny Bounes, Raquel Ferrandis, Corinne Frere...
https://pubmed.ncbi.nlm.nih.gov/38957023Antithrombotic therapy for VTE disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines.
Clive Kearon, Elie A Akl, Anthony J Comerota...
https://pubmed.ncbi.nlm.nih.gov/22315268American Society of Hematology 2018 guidelines for management of venous thromboembolism: prophylaxis for hospitalized and nonhospitalized medical patients.
Holger J Schünemann, Mary Cushman, Allison E Burnett...
https://pubmed.ncbi.nlm.nih.gov/30482763Omission of early thromboprophylaxis and mortality in critically ill patients: a multicenter registry study.
Kwok M Ho, Shaila Chavan, David Pilcher
https://pubmed.ncbi.nlm.nih.gov/21940768VTE Prophylaxis in Critically Ill Adults: A Systematic Review and Network Meta-analysis.
Shannon M Fernando, Alexandre Tran, Wei Cheng...
https://pubmed.ncbi.nlm.nih.gov/34419428Thromboprophylaxis patterns and determinants in critically ill patients: a multicenter audit.
François Lauzier, John Muscedere, Eric Deland...
https://pubmed.ncbi.nlm.nih.gov/24766968