NCT01511666

Brief Summary

Prague out-of Hospital Cardiac Arrest (OHCA) study is a prospective randomized multicenter clinical study comparing use of prehospital intraarrest hypothermia, mechanical chest compression device, extracorporeal life support (ECLS) and early invasive investigation and treatment (coronary angiography/percutaneous coronary intervention \[PCI\]; pulmonary angiography/percutaneous embolectomy; aortography) in all patients with OHCA of presumed cardiac origin compared to standard of care. It is hypothesized, that above stated "hyperinvasive" approach might improve outcome of out-of hospital cardiac arrest victims.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
256

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

January 13, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 19, 2012

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2020

Completed
Last Updated

March 15, 2021

Status Verified

March 1, 2021

Enrollment Period

7.7 years

First QC Date

January 13, 2012

Last Update Submit

March 11, 2021

Conditions

Out-of Hospital Cardiac Arrest

Keywords

cardiac arrestmechanical chest compressionsintraarrest coolingECLS

Outcome Measures

Primary Outcomes (1)

  • Composite endpoint of survival with good neurological outcome (CPC 1-2).

    6 months

Secondary Outcomes (2)

  • Neurological recovery

    30 days

  • Cardiac recovery

    30 days

Study Arms (2)

Hyperinvasive arm

EXPERIMENTAL

Hyperinvasive arm encompasses immediate institution of a mechanical chest compression device (LUCAS) and pre-hospital intraarrest cooling by Rhino-Chill device. Immediately after institution of these two devices the patients will be directly transferred to cardiac center cathlab under continuous CPR. The use of drugs and further defibrillations are on a discretion of the emergency physician. After admission to cathlab, overall status, ROSC presence and ECLS inclusion/exclusion criteria will be evaluated.

Device: Prehospital mechanical compressions, intraarrest cooling and in hospital ECLS

Standard arm

ACTIVE COMPARATOR

Patients in standard arm will be further managed as per recent ERC guidelines, ie. continued ACLS. The use of drugs and further defibrillations are on a discretion of the emergency physician. If ROSC is attained, patients will be transferred to the same hospital to one of intensive care units, coronary angiography/PCI will be performed only if indicated according to routine practice and mild therapeutic hypothermia will be instituted as soon as possible as per recent guidelines recommendation.

Other: Standard care

Interventions

Prehospital mechanical compressions, intraarrest cooling and in hospital ECLSDEVICE

ECLS states for extracorporeal life support.

Also known as: LUCAS, Rhinochill, ECLS
Hyperinvasive arm
Standard careOTHER

Standard care as per recent guidelines will be provided.

Standard arm

Eligibility Criteria

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

You may qualify if:

  • minimum of 18 and maximum of 65 years
  • witnessed out-of-hospital cardiac arrest of presumed cardiac cause
  • minimum of 5 minutes of ACLS performed by emergency medical service team without sustained ROSC
  • unconsciousness (Glasgow Coma Score \< 8)
  • ECMO team and bed-capacity in cardiac center available.

You may not qualify if:

  • OHCA of presumed non-cardiac cause
  • unwitnessed collapse
  • pregnancy
  • sustained ROSC within 5 minutes of ACLS performed by EMS team
  • conscious patient
  • known bleeding diathesis or suspected or confirmed acute or recent intracranial bleeding
  • suspected or confirmed acute stroke
  • known severe chronic organ dysfunction or other limitations in therapy
  • "do not resuscitate" order or other circumstances making 180 day survival unlikely
  • known pre-arrest cerebral performance category CPC ≥ 3.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Teaching Hospital

Prague, 128 02, Czechia

Location

Related Publications (7)

  • Smalcova J, Suen J, Huptych M, Franek O, Kavalkova P, Brodska HL, Balik M, Malik J, Pudil J, Smid O, Fajkus M, McInerney MR, Belohlavek J. The significance of possible non-occlusive mesenteric ischemia in relation to neurological outcomes in patients with refractory cardiac arrest - Secondary analysis of the Prague OHCA study. Resuscitation. 2025 Sep;214:110642. doi: 10.1016/j.resuscitation.2025.110642. Epub 2025 May 15.

    PMID: 40381979DERIVED

  • Rob D, Farkasovska K, Kreckova M, Smid O, Kavalkova P, Macoun J, Huptych M, Havrankova P, Gallo J, Pudil J, Dusik M, Havranek S, Linhart A, Belohlavek J. Effect of intra-arrest transport, extracorporeal cardiopulmonary resuscitation and immediate invasive assessment in refractory out-of-hospital cardiac arrest: a long-term follow-up of the Prague OHCA trial. Crit Care. 2024 Apr 16;28(1):125. doi: 10.1186/s13054-024-04901-7.

    PMID: 38627823DERIVED

  • Smalcova J, Havranek S, Pokorna E, Franek O, Huptych M, Kavalkova P, Pudil J, Rob D, Dusik M, Belohlavek J. Extracorporeal cardiopulmonary resuscitation-based approach to refractory out-of-hospital cardiac arrest: A focus on organ donation, a secondary analysis of a Prague OHCA randomized study. Resuscitation. 2023 Dec;193:109993. doi: 10.1016/j.resuscitation.2023.109993. Epub 2023 Oct 6.

    PMID: 37806620DERIVED

  • Dusik M, Rob D, Smalcova J, Havranek S, Karasek J, Smid O, Brodska HL, Kavalkova P, Huptych M, Bakker J, Belohlavek J. Serum lactate in refractory out-of-hospital cardiac arrest: Post-hoc analysis of the Prague OHCA study. Resuscitation. 2023 Nov;192:109935. doi: 10.1016/j.resuscitation.2023.109935. Epub 2023 Aug 11.

    PMID: 37574002DERIVED

  • Rob D, Smalcova J, Smid O, Kral A, Kovarnik T, Zemanek D, Kavalkova P, Huptych M, Komarek A, Franek O, Havranek S, Linhart A, Belohlavek J. Extracorporeal versus conventional cardiopulmonary resuscitation for refractory out-of-hospital cardiac arrest: a secondary analysis of the Prague OHCA trial. Crit Care. 2022 Oct 27;26(1):330. doi: 10.1186/s13054-022-04199-3.

    PMID: 36303227DERIVED

  • Belohlavek J, Smalcova J, Rob D, Franek O, Smid O, Pokorna M, Horak J, Mrazek V, Kovarnik T, Zemanek D, Kral A, Havranek S, Kavalkova P, Kompelentova L, Tomkova H, Mejstrik A, Valasek J, Peran D, Pekara J, Rulisek J, Balik M, Huptych M, Jarkovsky J, Malik J, Valerianova A, Mlejnsky F, Kolouch P, Havrankova P, Romportl D, Komarek A, Linhart A; Prague OHCA Study Group. Effect of Intra-arrest Transport, Extracorporeal Cardiopulmonary Resuscitation, and Immediate Invasive Assessment and Treatment on Functional Neurologic Outcome in Refractory Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2022 Feb 22;327(8):737-747. doi: 10.1001/jama.2022.1025.

    PMID: 35191923DERIVED

  • Belohlavek J, Kucera K, Jarkovsky J, Franek O, Pokorna M, Danda J, Skripsky R, Kandrnal V, Balik M, Kunstyr J, Horak J, Smid O, Valasek J, Mrazek V, Schwarz Z, Linhart A. Hyperinvasive approach to out-of hospital cardiac arrest using mechanical chest compression device, prehospital intraarrest cooling, extracorporeal life support and early invasive assessment compared to standard of care. A randomized parallel groups comparative study proposal. "Prague OHCA study". J Transl Med. 2012 Aug 10;10:163. doi: 10.1186/1479-5876-10-163.

    PMID: 22883307DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestHeart Arrest

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Jan Belohlavek

    General University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jan Belohlavek, MD, PhD., Consultant in Cardiology and Critical Care

Study Record Dates

First Submitted

January 13, 2012

First Posted

January 19, 2012

Study Start

March 1, 2013

Primary Completion

October 25, 2020

Study Completion

October 25, 2020

Last Updated

March 15, 2021

Record last verified: 2021-03

Locations

CZ(1)