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Completed

NCT Number: NCT06153160

"The Effect of the Use of an Autotransfusion 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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maribor University Medical Centre, Maribor, Urban Municipality of Maribor, Slovenia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • OHCA (Out of Hospital Cardiac Arrest)
  • age > 18 years
  • intubated
  • meets criteria for resuscitation

Exclusion criteria

  • 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

Treatment and study plan

HemaShock device

Device

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.

Primary outcomes

  1. Blood pressure

    Time frame: Immediately after arrival to the victim

    Non-invasive blood pressure (both systolic and diastolic blood pressure) will be measured.

  2. End tidal CO2 (Carbon dioxide) after intubation

    Time frame: Immediately after an intubation

    capnography

  3. End tidal CO2 (Carbon dioxide) after application of Hemashock Socks

    Time frame: Immediately after an application of Hemashock Socks

    capnography

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. End tidal CO2 (Carbon dioxide) after removal of HemaShock Socks

    Time frame: Immediately after the removal of HemaShock socks

    capnography

  11. Blood pressure

    Time frame: Immediately after ROSC

    Noninvasive blood pressure ((both systolic and diastolic blood pressure)) after removal of HemaShock Socks

Secondary outcomes

  1. Cerebral Performance Category Scale

    Time frame: Through study completion, an average of 1 year

    Neurological outcome assessed with Cerebral Performance Category Scale (CPC). CPC 1-2 means good outcome, CPC 3-5 means poor outcome.

  2. Tissue/skin malfunction under HemaShock Socks

    Time frame: From removal of the HemaShock socks up to 15 weeks

    Irrigation, oedema, tissue malperfusion

Sponsors and collaborators

Lead sponsor

University Medical Centre Maribor

Other

Collaborators

  • OHK Medical Devices

Registry information

Official study title

"The Effect of the Use of an Autotransfusion HemaShock Device on Hemodynamic Parameters During Resuscitation"

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Dec 1, 2023
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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