Pulsed Electromagnetic Field Therapy or Pneumatic Compression VTE Prophylaxis

NCT06958588 | Recruiting Phase 4

• 1 other identifier: CAAE: 86295325.3.1001.0229
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

venous thromboembolism; Mechanical prophylaxis; Pulsed Electromagnetic Field Therapy (PEMF); ICU; intensive care unit

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days

Study Arms (2)

Hyperslim

EXPERIMENTAL

Pulsed Electromagnetic Field Therapy (PEMF)

Device: Experimental: Hyperslim

Mechanical compression

ACTIVE COMPARATOR

Intermittent pneumatic compression ( Covidien Kendall SCD 700®, Cardinal Health or Doctor Life 2600® Venosan)

Device: Active Comparator #1

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).

Hyperslim

Active Comparator #1 DEVICE

The intermittent pneumatic compression group will use the devices Covidien Kendall SCD 700® (Cardinal Health) or Doctor Life 2600® (Venosan).

Mechanical compression

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Science Valley Research Institute: lead
• Hospital Vera Cruz: collaborator

Study Sites (1)

Hospital Vera Cruz, Belo Horizonte, MG, Brazil

Belo Horizonte, BH, 30190-130, Brazil

RECRUITING

Related Publications (8)

• Caprini JA. Mechanical methods for thrombosis prophylaxis. Clin Appl Thromb Hemost. 2010 Dec;16(6):668-73. doi: 10.1177/1076029609348645. Epub 2009 Oct 22.

  PMID: 19850588 BACKGROUND

• Nicolaides AN, Fareed J, Spyropoulos AC, Kakkar RHL, Antignani PL, Avgerinos E, Baekgaard N, Barber E, Bush RL, Caprini JA, Clarke-Pearson DL, VAN Dreden P, Elalami I, Gerotziafas G, Gibbs H, Goldhaber S, Kakkos S, Lefkou E, Labropoulos N, Lopes RD, Mansilha A, Papageorgiou C, Prandoni P, Ramacciotti E, Rognoni C, Urbanek T, Walenga JM. Prevention and management of venous thromboembolism. International Consensus Statement. Guidelines according to scientific evidence. Int Angiol. 2024 Feb;43(1):1-222. doi: 10.23736/S0392-9590.23.05177-5. No abstract available.

  PMID: 38421381 BACKGROUND

• Bounes F, Ferrandis R, Frere C, Helms J, Llau JV. European guidelines on peri-operative venous thromboembolism prophylaxis: first update.: Chapter 4: Prophylaxis in critical care patients. Eur J Anaesthesiol. 2024 Aug 1;41(8):582-588. doi: 10.1097/EJA.0000000000002011. Epub 2024 Jul 10. No abstract available.

  PMID: 38957023 BACKGROUND

• Kearon C, Akl EA, Comerota AJ, Prandoni P, Bounameaux H, Goldhaber SZ, Nelson ME, Wells PS, Gould MK, Dentali F, Crowther M, Kahn SR. Antithrombotic therapy for VTE disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e419S-e496S. doi: 10.1378/chest.11-2301.

  PMID: 22315268 BACKGROUND

• Schunemann HJ, Cushman M, Burnett AE, Kahn SR, Beyer-Westendorf J, Spencer FA, Rezende SM, Zakai NA, Bauer KA, Dentali F, Lansing J, Balduzzi S, Darzi A, Morgano GP, Neumann I, Nieuwlaat R, Yepes-Nunez JJ, Zhang Y, Wiercioch W. American Society of Hematology 2018 guidelines for management of venous thromboembolism: prophylaxis for hospitalized and nonhospitalized medical patients. Blood Adv. 2018 Nov 27;2(22):3198-3225. doi: 10.1182/bloodadvances.2018022954.

  PMID: 30482763 BACKGROUND

• Ho KM, Chavan S, Pilcher D. Omission of early thromboprophylaxis and mortality in critically ill patients: a multicenter registry study. Chest. 2011 Dec;140(6):1436-46. doi: 10.1378/chest.11-1444. Epub 2011 Sep 22.

  PMID: 21940768 BACKGROUND

• Fernando SM, Tran A, Cheng W, Sadeghirad B, Arabi YM, Cook DJ, Moller MH, Mehta S, Fowler RA, Burns KEA, Wells PS, Carrier M, Crowther MA, Scales DC, English SW, Kyeremanteng K, Kanji S, Kho ME, Rochwerg B. VTE Prophylaxis in Critically Ill Adults: A Systematic Review and Network Meta-analysis. Chest. 2022 Feb;161(2):418-428. doi: 10.1016/j.chest.2021.08.050. Epub 2021 Aug 19.

  PMID: 34419428 BACKGROUND

• Lauzier F, Muscedere J, Deland E, Kutsogiannis DJ, Jacka M, Heels-Ansdell D, Crowther M, Cartin-Ceba R, Cox MJ, Zytaruk N, Foster D, Sinuff T, Clarke F, Thompson P, Hanna S, Cook D; Co-operative Network of Critical Care Knowledge Translation for Thromboprophylaxis (CONECCKT-T) Investigators; Canadian Critical Care Trials Group. Thromboprophylaxis patterns and determinants in critically ill patients: a multicenter audit. Crit Care. 2014 Apr 25;18(2):R82. doi: 10.1186/cc13844.

  PMID: 24766968 BACKGROUND

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Eduardo Ramacciotti, MD, Ph.D.

  Science Valley Research Organization

  STUDY CHAIR

Central Study Contacts

Eduardo Fonseca Sad, MD

CONTACT

+55 31 991717860; edu.sad@uol.com.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: May 6, 2025
• Study Start: May 25, 2025
• Primary Completion: December 20, 2025
• Study Completion: March 20, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: March 2025 to March 2030
• Access Criteria: Anonymized participant data can be made available upon requests directed to the corresponding author. Proposals will be reviewed based on scientific merit. After approval of a proposal, data can be shared through a secure online platform after signing a data access agreement.

Locations

BR (1)