Venous Thromboembolism (VTE)Phase 4SOPHIENCT06958588
Pulsed Electromagnetic Field Therapy or Pneumatic Compression VTE Prophylaxis
A Phase 4 study testing Experimental: Hyperslim and Active Comparator #1 in people with Venous Thromboembolism (VTE) and Intensive Care Medicine, run by Science Valley Research Institute at 1 site in Brazil.
Trial summary
Venous thromboembolism (VTE) is frequent in patients in the intensive care unit (ICU). Pharmacologic prophylaxis is sometimes contraindicated, and mechanical prophylaxis is used. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Venous Thromboembolism (VTE), Intensive Care Medicine, Venous Thromboembolism
- What is being tested?
- Experimental: Hyperslim and Active Comparator #1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 25 May 2025to 20 Mar 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Vera Cruz, Belo Horizonte, MG, Brazil
Belo Horizonte, BH, 30190-130
Eduardo Fonseca Sad, MD, +55 31 991717860, edu.sad@uol.com.br
About this study
Official title: Pulsed Electromagnetic Field Therapy (PEMF) Compared to Conventional Mechanical Prophylaxis for Venous Thromboembolism Prophylaxis in Patients in the Intensive Care Unit (ICU)
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.
Read the detailed description
This study is a prospective, randomized, open-label, active-controlled study, patients with indication for mechanical VTE prophylaxis or combined mechanical and pharmacological in the ICU from 2 selected sites in Brazil (Vera Cruz Hospital and Felicio Rocho Hospital, both in Belo Horizonte-MG, Brazil) will be enrolled after signing informed consent. All data will be recorded with a pre-established clinical recording file (CRF - RedCap) to demographics, risk factors, and clinical aspects of the patient's comorbidities.
A trained team member will perform clinical diagnosis and standard clinical evaluations, including imaging when indicated. Patients will be considered eligible if they are> 18 years old, have a PADUA score > 4 (medical patients) and/or Caprini > of 3 (surgical patients), and have a contraindication to pharmacological prophylaxis or indication to combined (pharmacological and mechanical VTE prophylaxis).
After signing informed consent, the patients will be screened and included in the study. After ICU admission, the patient will be interviewed by study investigators or trained physicians or nurses; inclusion patients will be randomized to receive either PEMF or intermittent pneumatic compression.
The devices will be placed in the ICUs following institutional standards and operational procedures. After randomization, trained physiotherapy and nurse teams will place and monitor each device. The intermittent pneumatic compression group will use the devices Covidien Kendall SCD 700® (Cardinal Health) or Doctor Life 2600® (Venosan). This group will have the device placed in the lower limbs, following the manufacturer's instructions, and monitored for 24 hours according to previous institutional protocol. This device will be kept full-time working in the patients while in the ICU.
The PEMF will be carried out using the Hyperslim® device. The Hyperslim® device is produced by Medical San (Lageado, RS, Brazil). It generates electromagnetic pulses through its pads, leading to local muscular supra-maximal contractions sustained for several seconds, increasing stress and workload without muscular adaptation. Its pads will be placed in the patient's lower limbs and used for 30 minutes thrice daily.
The critical care team will monitor patients 24 hours/day for VTE signs and symptoms, laboratory changes, and adverse local effects caused by machines like skin lesions, burns, and edema. A tolerability scale will be applied to every awake patient able to answer using a scale: 1= well tolerated; 2= tolerate with little discomfort; 3= tolerate with discomfort; 4= Not tolerated.
At the end of mechanical prophylaxis, patients will be evaluated for thromboembolic events, including diagnosis by imaging, with a mandatory Doppler ultrasound of the lower limbs at ICU discharge and 30 days post-randomization.
The primary efficacy outcome is a combination of symptomatic + asymptomatic VTE events at day 30 post randomization.
Evaluation also includes major bleeding events, defined as leading to transfusion of 2 or more units of blood or packed red cells, decrease in hemoglobin of 2 g/dL, bleeding in critical sites, defined as spinal, epidural, intraocular, intracranial, pericardial or retroperitoneal, local adverse events, including adverse events related to the use of the devices.
For descriptive statistics, mean and SD will be calculated for data following a Gaussian distribution.
The difference in VTE events between the two groups at the end of mechanical prophylaxis and day 30 will be tested using the intention-to-treat principle.
The efficacy analysis tests will be one-sided, with a type I error rate of 2·5%, assuming a two-sided 95% CI. The cumulative incidence of the composite events will be compared between the test and control groups, and the relative risk (RR) or risk ratio will be estimated. For the safety analysis, statistical tests will be two-sided, with a type I error rate of 5% and a two-sided 95% CI.
Tolerability, security, and facility to implement PEMF will be compared with intermittent pneumatic compression using an unpaired t-test.
- Being tested
- Experimental: Hyperslim, Active Comparator #1
- Keywords
- venous thromboembolism, Mechanical prophylaxis, Pulsed Electromagnetic Field Therapy (PEMF), ICU, intensive care unit
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: HyperslimDevice
The PEMF will be carried out using the Hyperslim® device. The Hyperslim® device is produced by Medical San (Lageado, RS, Brazil).
Active Comparator #1Device
The intermittent pneumatic compression group will use the devices Covidien Kendall SCD 700® (Cardinal Health) or Doctor Life 2600® (Venosan).
| Study group | Role | What they receive |
|---|---|---|
| Hyperslim | Experimental | Pulsed Electromagnetic Field Therapy (PEMF) Receives: Device: Experimental: Hyperslim |
| Mechanical compression | Active comparator | Intermittent pneumatic compression ( Covidien Kendall SCD 700®, Cardinal Health or Doctor Life 2600® Venosan) Receives: Device: Active Comparator #1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start25 May 2025 (estimated)
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Venous Thromboembolism (VTE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Science Valley Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Vera Cruz
- Responsible party
- Sponsor
- Investigators
- Eduardo Ramacciotti, MD, Ph.D., Study chair, Science Valley Research Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958588
- Sponsor's protocol ID
- CAAE: 86295325.3.1001.0229
- Acronym
- SOPHIE
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 19850588Nicolaides 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.
PubMed 38421381Bounes 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.
PubMed 38957023Kearon 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.
PubMed 22315268Schunemann 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.
PubMed 30482763Ho 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.
PubMed 21940768Fernando 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.
PubMed 34419428Lauzier 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.
PubMed 24766968
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Electromagnetic Field Therapy (PEMF) Compared to Conventional Mechanical Prophylaxis for Venous Thromboembolism Prophylaxis in Patients in the Intensive Care Unit (ICU)
- ClinicalTrials.gov ID
- NCT06958588
- Acronym / sponsor ID
- SOPHIE / CAAE: 86295325.3.1001.0229
- Keywords
- venous thromboembolism, Mechanical prophylaxis, Pulsed Electromagnetic Field Therapy (PEMF), ICU, intensive care unit
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Science Valley Research InstituteUniversity, hospital or other
- Collaborators
- Hospital Vera Cruz
- Study start
- 25 May 2025 (estimated)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 20 Mar 2026 (estimated)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a prospective, randomized, open-label, active-controlled study, patients with indication for mechanical VTE prophylaxis or combined mechanical and pharmacological in the ICU from 2 selected sites in Brazil (Vera Cruz Hospital and Felicio Rocho Hospital, both in Belo Horizonte-MG, Brazil) will be enrolled after signing informed consent. All data will be recorded with a pre-established clinical recording file (CRF - RedCap) to demographics, risk factors, and clinical aspects of the patient's comorbidities.
A trained team member will perform clinical diagnosis and standard clinical evaluations, including imaging when indicated. Patients will be considered eligible if they are> 18 years old, have a PADUA score > 4 (medical patients) and/or Caprini > of 3 (surgical patients), and have a contraindication to pharmacological prophylaxis or indication to combined (pharmacological and mechanical VTE prophylaxis).
After signing informed consent, the patients will be screened and included in the study. After ICU admission, the patient will be interviewed by study investigators or trained physicians or nurses; inclusion patients will be randomized to receive either PEMF or intermittent pneumatic compression.
The devices will be placed in the ICUs following institutional standards and operational procedures. After randomization, trained physiotherapy and nurse teams will place and monitor each device. The intermittent pneumatic compression group will use the devices Covidien Kendall SCD 700® (Cardinal Health) or Doctor Life 2600® (Venosan). This group will have the device placed in the lower limbs, following the manufacturer's instructions, and monitored for 24 hours according to previous institutional protocol. This device will be kept full-time working in the patients while in the ICU.
The PEMF will be carried out using the Hyperslim® device. The Hyperslim® device is produced by Medical San (Lageado, RS, Brazil). It generates electromagnetic pulses through its pads, leading to local muscular supra-maximal contractions sustained for several seconds, increasing stress and workload without muscular adaptation. Its pads will be placed in the patient's lower limbs and used for 30 minutes thrice daily.
The critical care team will monitor patients 24 hours/day for VTE signs and symptoms, laboratory changes, and adverse local effects caused by machines like skin lesions, burns, and edema. A tolerability scale will be applied to every awake patient able to answer using a scale: 1= well tolerated; 2= tolerate with little discomfort; 3= tolerate with discomfort; 4= Not tolerated.
At the end of mechanical prophylaxis, patients will be evaluated for thromboembolic events, including diagnosis by imaging, with a mandatory Doppler ultrasound of the lower limbs at ICU discharge and 30 days post-randomization.
The primary efficacy outcome is a combination of symptomatic + asymptomatic VTE events at day 30 post randomization.
Evaluation also includes major bleeding events, defined as leading to transfusion of 2 or more units of blood or packed red cells, decrease in hemoglobin of 2 g/dL, bleeding in critical sites, defined as spinal, epidural, intraocular, intracranial, pericardial or retroperitoneal, local adverse events, including adverse events related to the use of the devices.
For descriptive statistics, mean and SD will be calculated for data following a Gaussian distribution.
The difference in VTE events between the two groups at the end of mechanical prophylaxis and day 30 will be tested using the intention-to-treat principle.
The efficacy analysis tests will be one-sided, with a type I error rate of 2·5%, assuming a two-sided 95% CI. The cumulative incidence of the composite events will be compared between the test and control groups, and the relative risk (RR) or risk ratio will be estimated. For the safety analysis, statistical tests will be two-sided, with a type I error rate of 5% and a two-sided 95% CI.
Tolerability, security, and facility to implement PEMF will be compared with intermittent pneumatic compression using an unpaired t-test.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperslim | Experimental | Device: Experimental: HyperslimPulsed Electromagnetic Field Therapy (PEMF) |
| Mechanical compression | Active comparator | Device: Active Comparator #1Intermittent pneumatic compression ( Covidien Kendall SCD 700®, Cardinal Health or Doctor Life 2600® Venosan) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: HyperslimThe PEMF will be carried out using the Hyperslim® device. The Hyperslim® device is produced by Medical San (Lageado, RS, Brazil). | Device | Hyperslim |
| Active Comparator #1The intermittent pneumatic compression group will use the devices Covidien Kendall SCD 700® (Cardinal Health) or Doctor Life 2600® (Venosan). | Device | Mechanical compression |
Primary outcome
Primary efficacy outcome
Time frame: 30 days
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Background: PubMed 19850588Caprini JA. Mechanical methods for thrombosis prophylaxis. Clin Appl Thromb Hemost. 2010 Dec;16(6):668-73. doi: 10.1177/1076029609348645. Epub 2009 Oct 22.
- Background: PubMed 38421381Nicolaides 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.
- Background: PubMed 38957023Bounes 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.
- Background: PubMed 22315268Kearon 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.
- Background: PubMed 30482763Schunemann 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.
- Background: PubMed 21940768Ho 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.
- Background: PubMed 34419428Fernando 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.
- Background: PubMed 24766968Lauzier 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eduardo Ramacciotti, MD, Ph.D. study chair
Science Valley Research Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Experimental: Hyperslim and Active Comparator #1 in people with Venous Thromboembolism (VTE) and Intensive Care Medicine, run by Science Valley Research Institute at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eduardo Fonseca Sad, MD (+55 31 991717860, edu.sad@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy outcome (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06958588, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025; AzTrials last refreshed its copy on 27 Oct 2026.