Out of Hospital Cardiac ArrestNCT06153160
"The Effect of the Use of an Autotransfusion Device on Hemodynamic Parameters During Resuscitation".
A study testing HemaShock device in people with Out of Hospital Cardiac Arrest and Cardiac Arrest, run by University Medical Centre Maribor at 2 sites in Slovenia.
Trial summary
The purpose of the research (pilot study) is to determine the impact of the use of the autotransfusion device on hemodynamic parameters during resuscitation. 24 people will be included in the pilot study (12 people will be included in the intervention group - with the usage of "autotransfusion socks" during… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Out of Hospital Cardiac Arrest, Cardiac Arrest
- What is being tested?
- HemaShock device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesSlovenia
- Study dates
- 22 Nov 2023to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- OHCA (Out of Hospital Cardiac Arrest)
- age > 18 years
- intubated
- meets criteria for resuscitation
Who cannot join
- age < 18 years
- not intubated
- clinical signs for DVT (deep vein thrombosis), PE (pulmonary embolism)
- clinical signs of acute inflammation of limbs, broken limbs etc.
- known oncological patient
- asphyxia
- trauma patients
Trial locations and contacts
2 sites in 1 country.
Slovenia2 sites
Maribor University Medical Centre
Maribor, Urban Municipality of Maribor, 2000
Community health center Maribor, Prehospital unit
Maribor, 2000
About this study
Official title: "The Effect of the Use of an Autotransfusion HemaShock Device on Hemodynamic Parameters During Resuscitation"
The purpose of the research (pilot study) is to determine the impact of the use of the autotransfusion device on hemodynamic parameters during resuscitation.
24 people will be included in the pilot study (12 people will be included in the intervention group - with the usage of "autotransfusion socks" during resuscitation and 12 people in the control group - without "autotransfusion socks"). Investigators will compare the hemodynamic parameters and also neurological outcome between both groups.
Read the detailed description
The purpose of the research (pilot study) is to determine the impact of the use of the autotransfusion device on hemodynamic parameters during resuscitation.
Out-of-hospital cardiac arrest (OHCA) is one of the leading causes of death in Europe.
In order to improve the hemodynamic parameters during resuscitation, device for autotransfusion was developed. Devices are basically a very strong elastic stockings that also block arterial circulation. While "putting on" stockings, blood is being squeezed from the lower extremities (approximately 500 ml of blood for each lower limb). With blood being squeezed from the lower limb into the central circulation the filling of the heart is being improved; thus the device will improve the preload and also cardiac output.
A study done on an animal model showed that during resuscitation using "autotransfusion socks" increases both systolic and diastolic blood pressure during resuscitation, the perfusion of the coronary arteries improves and also the values of the partial pressure of carbon dioxide increases.
- Conditions
- Out of Hospital Cardiac Arrest, Cardiac Arrest
- Being tested
- HemaShock device
- Keywords
- Cardiac Arrest, Out of Hospital Cardiac Arrest, Resuscitation
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemaShock deviceDevice
The HemaShock is a tight silicone ring attached to a pressure stocking. It comes wrapped into a doughnut and has a set of handles. The operator simply puts the doughnut over the foot or hand, and pulls on the handles to unravel the HemaShock while applying pressure throughout the appendage. The device displace blood from limbs to central blood system, thus improving preload and cardiac output.
| Study group | Role | What they receive |
|---|---|---|
| Patients with HemaShock device | Experimental | 12 patients in cardiac arrest will receive HemaShock device during resuscitation.
All other interventions will be made following guidelines. Receives: Device: HemaShock device |
| Patients with-out HemaShock device | No intervention | 12 patients in cardiac arrest will not receive HemaShock device during resuscitation. All other interventions will be made following guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Non-invasive blood pressure (both systolic and diastolic blood pressure) will be measured.
Measured: Immediately after arrival to the victim
End tidal CO2 (Carbon dioxide) after intubation
capnography
Measured: Immediately after an intubation
End tidal CO2 (Carbon dioxide) after application of Hemashock Socks
capnography
Measured: Immediately after an application of Hemashock Socks
End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks
capnography
Measured: 5 minutes after the first application of HemaShock socks
End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks
capnography
Measured: 10 minutes after the first application of HemaShock socks
End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks
capnography
Measured: 15 minutes after the first application of HemaShock socks
End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks
capnography
Measured: 20 minutes after the first application of HemaShock socks
End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks
capnography
Measured: 25 minutes after the first application of HemaShock socks
End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks
capnography
Measured: 30 minutes after the first application of HemaShock socks
End tidal CO2 (Carbon dioxide) after removal of HemaShock Socks
capnography
Measured: Immediately after the removal of HemaShock socks
Blood pressure
Noninvasive blood pressure ((both systolic and diastolic blood pressure)) after removal of HemaShock Socks
Measured: Immediately after ROSC
Secondary outcomes (2)
Cerebral Performance Category Scale
Neurological outcome assessed with Cerebral Performance Category Scale (CPC). CPC 1-2 means good outcome, CPC 3-5 means poor outcome.
Measured: Through study completion, an average of 1 year
Tissue/skin malfunction under HemaShock Socks
Irrigation, oedema, tissue malperfusion
Measured: From removal of the HemaShock socks up to 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start22 Nov 2023
- Primary completion30 Dec 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Out of Hospital Cardiac ArrestStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Maribor
- Sponsor type
- University, hospital or other
- Collaborators
- OHK Medical Devices
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153160
- Sponsor's protocol ID
- HemaShock socks
- Status last verified
- Mar 2025
- First submitted
- 28 Feb 2023
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boyce LW, Vliet Vlieland TP, Bosch J, Wolterbeek R, Volker G, van Exel HJ, Heringhaus C, Schalij MJ, Goossens PH. High survival rate of 43% in out-of-hospital cardiac arrest patients in an optimised chain of survival. Neth Heart J. 2015 Jan;23(1):20-5. doi: 10.1007/s12471-014-0617-x.
PubMed 25326102Olasveengen TM, Semeraro F, Ristagno G, Castren M, Handley A, Kuzovlev A, Monsieurs KG, Raffay V, Smyth M, Soar J, Svavarsdottir H, Perkins GD. European Resuscitation Council Guidelines 2021: Basic Life Support. Resuscitation. 2021 Apr;161:98-114. doi: 10.1016/j.resuscitation.2021.02.009. Epub 2021 Mar 24.
PubMed 33773835Soar J, Bottiger BW, Carli P, Couper K, Deakin CD, Djarv T, Lott C, Olasveengen T, Paal P, Pellis T, Perkins GD, Sandroni C, Nolan JP. European Resuscitation Council Guidelines 2021: Adult advanced life support. Resuscitation. 2021 Apr;161:115-151. doi: 10.1016/j.resuscitation.2021.02.010. Epub 2021 Mar 24.
PubMed 33773825Aminiahidashti H, Shafiee S, Zamani Kiasari A, Sazgar M. Applications of End-Tidal Carbon Dioxide (ETCO2) Monitoring in Emergency Department; a Narrative Review. Emerg (Tehran). 2018;6(1):e5. Epub 2018 Jan 15.
PubMed 29503830Yang Z, Tang D, Wu X, Hu X, Xu J, Qian J, Yang M, Tang W. A tourniquet assisted cardiopulmonary resuscitation augments myocardial perfusion in a porcine model of cardiac arrest. Resuscitation. 2015 Jan;86:49-53. doi: 10.1016/j.resuscitation.2014.10.009. Epub 2014 Oct 23.
PubMed 25447436
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Effect of the Use of an Autotransfusion HemaShock Device on Hemodynamic Parameters During Resuscitation"
- ClinicalTrials.gov ID
- NCT06153160
- Acronym / sponsor ID
- HemaShock socks
- Conditions
- Out of Hospital Cardiac Arrest, Cardiac Arrest
- Keywords
- Cardiac Arrest, Out of Hospital Cardiac Arrest, Resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Medical Centre MariborUniversity, hospital or other
- Collaborators
- OHK Medical Devices
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 1 Dec 2023 (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.
The purpose of the research (pilot study) is to determine the impact of the use of the autotransfusion device on hemodynamic parameters during resuscitation.
24 people will be included in the pilot study (12 people will be included in the intervention group - with the usage of "autotransfusion socks" during resuscitation and 12 people in the control group - without "autotransfusion socks"). Investigators will compare the hemodynamic parameters and also neurological outcome between both groups.
Detailed description
The purpose of the research (pilot study) is to determine the impact of the use of the autotransfusion device on hemodynamic parameters during resuscitation.
Out-of-hospital cardiac arrest (OHCA) is one of the leading causes of death in Europe.
In order to improve the hemodynamic parameters during resuscitation, device for autotransfusion was developed. Devices are basically a very strong elastic stockings that also block arterial circulation. While "putting on" stockings, blood is being squeezed from the lower extremities (approximately 500 ml of blood for each lower limb). With blood being squeezed from the lower limb into the central circulation the filling of the heart is being improved; thus the device will improve the preload and also cardiac output.
A study done on an animal model showed that during resuscitation using "autotransfusion socks" increases both systolic and diastolic blood pressure during resuscitation, the perfusion of the coronary arteries improves and also the values of the partial pressure of carbon dioxide increases.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with HemaShock device | Experimental | Device: HemaShock device12 patients in cardiac arrest will receive HemaShock device during resuscitation. All other interventions will be made following guidelines. |
| Patients with-out HemaShock device | No intervention | –12 patients in cardiac arrest will not receive HemaShock device during resuscitation. All other interventions will be made following guidelines. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- OHCA (Out of Hospital Cardiac Arrest)
- age > 18 years
- intubated
- meets criteria for resuscitation
Key exclusion criteria (7 listed)
- age < 18 years
- not intubated
- clinical signs for DVT (deep vein thrombosis), PE (pulmonary embolism)
- clinical signs of acute inflammation of limbs, broken limbs etc.
- known oncological patient
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 |
|---|---|---|
| HemaShock deviceThe HemaShock is a tight silicone ring attached to a pressure stocking. It comes wrapped into a doughnut and has a set of handles. The operator simply puts the doughnut over the foot or hand, and pulls on the handles to unravel the HemaShock while applying pressure throughout the appendage. The device displace blood from limbs to central blood system, thus improving preload and cardiac output. | Device | Patients with HemaShock device |
Primary outcome
Blood pressure
Time frame: Immediately after arrival to the victim
Non-invasive blood pressure (both systolic and diastolic blood pressure) will be measured.
End tidal CO2 (Carbon dioxide) after intubation
Time frame: Immediately after an intubation
capnography
End tidal CO2 (Carbon dioxide) after application of Hemashock Socks
Time frame: Immediately after an application of Hemashock Socks
capnography
End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks
Time frame: 5 minutes after the first application of HemaShock socks
capnography
End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks
Time frame: 10 minutes after the first application of HemaShock socks
capnography
End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks
Time frame: 15 minutes after the first application of HemaShock socks
capnography
End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks
Time frame: 20 minutes after the first application of HemaShock socks
capnography
End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks
Time frame: 25 minutes after the first application of HemaShock socks
capnography
End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks
Time frame: 30 minutes after the first application of HemaShock socks
capnography
End tidal CO2 (Carbon dioxide) after removal of HemaShock Socks
Time frame: Immediately after the removal of HemaShock socks
capnography
Blood pressure
Time frame: Immediately after ROSC
Noninvasive blood pressure ((both systolic and diastolic blood pressure)) after removal of HemaShock Socks
2 secondary outcomes
Cerebral Performance Category Scale
Time frame: Through study completion, an average of 1 year
Tissue/skin malfunction under HemaShock Socks
Time frame: From removal of the HemaShock socks up to 15 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Background: PubMed 25326102Boyce LW, Vliet Vlieland TP, Bosch J, Wolterbeek R, Volker G, van Exel HJ, Heringhaus C, Schalij MJ, Goossens PH. High survival rate of 43% in out-of-hospital cardiac arrest patients in an optimised chain of survival. Neth Heart J. 2015 Jan;23(1):20-5. doi: 10.1007/s12471-014-0617-x.
- Background: PubMed 33773835Olasveengen TM, Semeraro F, Ristagno G, Castren M, Handley A, Kuzovlev A, Monsieurs KG, Raffay V, Smyth M, Soar J, Svavarsdottir H, Perkins GD. European Resuscitation Council Guidelines 2021: Basic Life Support. Resuscitation. 2021 Apr;161:98-114. doi: 10.1016/j.resuscitation.2021.02.009. Epub 2021 Mar 24.
- Background: PubMed 33773825Soar J, Bottiger BW, Carli P, Couper K, Deakin CD, Djarv T, Lott C, Olasveengen T, Paal P, Pellis T, Perkins GD, Sandroni C, Nolan JP. European Resuscitation Council Guidelines 2021: Adult advanced life support. Resuscitation. 2021 Apr;161:115-151. doi: 10.1016/j.resuscitation.2021.02.010. Epub 2021 Mar 24.
- Background: PubMed 29503830Aminiahidashti H, Shafiee S, Zamani Kiasari A, Sazgar M. Applications of End-Tidal Carbon Dioxide (ETCO2) Monitoring in Emergency Department; a Narrative Review. Emerg (Tehran). 2018;6(1):e5. Epub 2018 Jan 15.
- Background: PubMed 25447436Yang Z, Tang D, Wu X, Hu X, Xu J, Qian J, Yang M, Tang W. A tourniquet assisted cardiopulmonary resuscitation augments myocardial perfusion in a porcine model of cardiac arrest. Resuscitation. 2015 Jan;86:49-53. doi: 10.1016/j.resuscitation.2014.10.009. Epub 2014 Oct 23.
- Individual participant dataSharing planned: No
Related trials for Out of Hospital Cardiac Arrest
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HemaShock device in people with Out of Hospital Cardiac Arrest and Cardiac Arrest, run by University Medical Centre Maribor at 2 sites in Slovenia.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Slovenia. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: Immediately after arrival to the victim). The study lists 11 primary outcomes in all. 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 NCT06153160, which also lists 5 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 30 Mar 2025.