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

Last updated: March 25, 2025
Sponsor: University Medical Centre Maribor
Overall Status: Completed

Phase

N/A

Condition

Heart Attack (Myocardial Infarction)

Heart Failure

Circulation Disorders

Treatment

HemaShock device

Clinical Study ID

NCT06153160
HemaShock socks
  • Ages 18-90
  • All Genders
  • Accepts Healthy Volunteers

Study 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 resuscitation and 12 people in the control group - without "autotransfusion socks"). Investigators will compare the hemodynamic parameters and also neurological outcome between both groups.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • OHCA (Out of Hospital Cardiac Arrest)

  • age > 18 years

  • intubated

  • meets criteria for resuscitation

Exclusion

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

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: HemaShock device
Phase:
Study Start date:
November 22, 2023
Estimated Completion Date:
March 01, 2025

Study 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.

Connect with a study center

  • Community health center Maribor, Prehospital unit

    Maribor, 2000
    Slovenia

    Site Not Available

  • Maribor University Medical Centre

    Maribor, 2000
    Slovenia

    Site Not Available

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