NCT06153160

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

November 22, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

1.1 years

First QC Date

February 28, 2023

Last Update Submit

March 25, 2025

Conditions

Out of Hospital Cardiac ArrestCardiac Arrest

Keywords

Cardiac ArrestOut of Hospital Cardiac ArrestResuscitation

Outcome Measures

Primary Outcomes (11)

  • Blood pressure

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

    Immediately after arrival to the victim

  • End tidal CO2 (Carbon dioxide) after intubation

    capnography

    Immediately after an intubation

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

    capnography

    Immediately after an application of Hemashock Socks

  • End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks

    capnography

    5 minutes after the first application of HemaShock socks

  • End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks

    capnography

    10 minutes after the first application of HemaShock socks

  • End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks

    capnography

    15 minutes after the first application of HemaShock socks

  • End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks

    capnography

    20 minutes after the first application of HemaShock socks

  • End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks

    capnography

    25 minutes after the first application of HemaShock socks

  • End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks

    capnography

    30 minutes after the first application of HemaShock socks

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

    capnography

    Immediately after the removal of HemaShock socks

  • Blood pressure

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

    Immediately after ROSC

Secondary Outcomes (2)

  • Cerebral Performance Category Scale

    Through study completion, an average of 1 year

  • Tissue/skin malfunction under HemaShock Socks

    From removal of the HemaShock socks up to 15 weeks

Study Arms (2)

Patients with HemaShock device

EXPERIMENTAL

12 patients in cardiac arrest will receive HemaShock device during resuscitation. All other interventions will be made following guidelines.

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.

Interventions

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.

Patients with HemaShock device

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Maribor University Medical Centre

Maribor, Maribor City Municipality, 2000, Slovenia

Location

Community health center Maribor, Prehospital unit

Maribor, 2000, Slovenia

Location

Related Publications (5)

  • 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.

    PMID: 25326102BACKGROUND

  • Olasveengen 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.

    PMID: 33773835BACKGROUND

  • Soar 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.

    PMID: 33773825BACKGROUND

  • Aminiahidashti 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.

    PMID: 29503830BACKGROUND

  • Yang 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.

    PMID: 25447436BACKGROUND

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestHeart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2023

First Posted

December 1, 2023

Study Start

November 22, 2023

Primary Completion

December 30, 2024

Study Completion

March 1, 2025

Last Updated

March 30, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

SL(2)