Comparing Pulsed Electromagnetic Field Therapy and Pneumatic Compression for Preventing Blood Clots in ICU Patients
Pulsed Electromagnetic Field Therapy (PEMF) Compared to Conventional Mechanical Prophylaxis for Venous Thromboembolism Prophylaxis in Patients in the Intensive Care Unit (ICU)
This study is testing whether Pulsed Electromagnetic Field Therapy works better than pneumatic compression to prevent blood clots in ICU patients who can't take medication for it.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Sex | All |
| Sponsor | Science Valley Research Institute Academic / other |
| Locations | 1 site (Belo Horizonte, BH) |
| Trial ID | NCT06958588 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Pulsed Electromagnetic Field Therapy (PEMF) compared to conventional pneumatic compression for preventing venous thromboembolism (VTE) in patients admitted to the intensive care unit (ICU). It is a prospective, randomized, open-label study involving patients who are at risk for VTE and cannot receive pharmacological prophylaxis. Participants will be enrolled from two hospitals in Belo Horizonte, Brazil, and will be monitored using standardized clinical evaluations and data collection methods. The study will assess the outcomes of both interventions to determine which is more effective in preventing VTE.
Who should consider this trial
Good fit: Ideal candidates are ICU patients over 18 years old with a PADUA score greater than 4 or a Caprini score greater than 3, who have contraindications to pharmacological prophylaxis.
Not a fit: Patients under 18 years old, those unable to use mechanical prophylaxis due to physical limitations, or those with a life expectancy of less than 24 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-pharmacological option for preventing blood clots in ICU patients who cannot take traditional medications.
How similar studies have performed: Other studies have explored mechanical prophylaxis for VTE, but the specific use of PEMF therapy in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients \> 18 years old in ICU 2. PADUA score\> 4 (medical patients) and/or Caprini score\> 3 (surgical patients) 3. Contraindication to pharmacological prophylaxis or indication to combined (pharmacological and mechanical VTE prophylaxis) Exclusion Criteria: 1. Patients \< 18 years old in ICU 2. Unable to use mechanical prophylaxis due to trauma, burns, fracture, or problems in inferior members that prevent the use of mechanical prophylaxis 3. Life expectations less than 24 hours
Where this trial is running
Belo Horizonte, BH
- Hospital Vera Cruz, Belo Horizonte, MG, Brazil — Belo Horizonte, Bh, Brazil (Recruiting)
Study contacts
- Study coordinator: Eduardo Fonseca Sad, MD
- Email: edu.sad@uol.com.br
- Phone: +55 31 991717860
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.