Out-of Hospital Cardiac ArrestNCT01511666
Hyperinvasive Approach in Cardiac Arrest
A study testing Prehospital mechanical compressions, intraarrest cooling and in hospital ECLS in people with Out-of Hospital Cardiac Arrest, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Out-of Hospital Cardiac Arrest
- What is being tested?
- Prehospital mechanical compressions, intraarrest cooling and in hospital ECLS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteCzechia
- Study dates
- Mar 2013to 25 Oct 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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. "Prague OHCA Study"
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.
Read the detailed description
Background: Out of hospital cardiac arrest (OHCA) has a poor outcome. Recent non-randomized study of ECLS (extracorporeal life support) in OHCA suggested further prospective multicenter studies to define population with OHCA that would benefit from ECLS.
Aim: to perform a prospective randomized multicenter clinical study comparing use of prehospital intraarrest hypothermia, mechanical chest compression device, 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.
Planned intervention: patients with witnessed OHCA without ROSC (return of spontaneous circulation) after a minimum of 5 minutes of ACLS by emergency medical service (EMS) team will be after fulfilling of inclusion/exclusion criteria for the study randomized in a 1:1 design to standard vs. hyperinvasive arm. Patients in standard arm will be further managed as per recent guidelines. In hyperinvasive arm, mechanical compression device together with intranasal cooling will be immediately instituted and patients will be transferred to cardiac center directly to cathlab under ongoing CPR. After admission to cathlab, overall status, ROSC and ECLS inclusion/exclusion criteria will be evaluated and in case of no contraindications to ECLS and no ROSC or ROSC with shock, veno-arterial ECLS will be started as soon as possible, not later than 60 minutes after cardiac arrest onset. After ECLS institution, mild hypothermia will be continued by means of ECLS cooling and immediate invasive investigation will be performed in all patients.
Standard postresuscitation care will follow.
- Conditions
- Out-of Hospital Cardiac Arrest
- Being tested
- Prehospital mechanical compressions, intraarrest cooling and in hospital ECLS, Standard care
- Keywords
- cardiac arrest, mechanical chest compressions, intraarrest cooling, ECLS
- 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.
Prehospital mechanical compressions, intraarrest cooling and in hospital ECLSDevice
Also called LUCAS, Rhinochill, ECLS
ECLS states for extracorporeal life support.
Standard careOther
Standard care as per recent guidelines will be provided.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of survival with good neurological outcome (CPC 1-2).
Measured: 6 months
Secondary outcomes (2)
Neurological recovery
Neurological recovery will be defined as no or minimal neurological impairment (CPC 1 or 2) at any timepoint within first 30 days after initial cardiac arrest.
Measured: 30 days
Cardiac recovery
Cardiac recovery will be assessed by the clinical status of hemodynamic stability defined as no need for pharmacological or mechanical cardiac support. Systolic function will be measured by echocardiography .
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startMar 2013
- Primary completion25 Oct 2020
- Study completion25 Oct 2020
Why it stopped: DSMB recommendation to stop
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Belohlavek, Charles University, Czech Republic
- Investigators
- Jan Belohlavek, Principal investigator, General University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511666
- Sponsor's protocol ID
- Prague OHCA study
- Status last verified
- Mar 2021
- First submitted
- 13 Jan 2012
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40381979Rob 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.
PubMed 38627823Smalcova 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.
PubMed 37806620Dusik 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.
PubMed 37574002Rob 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.
PubMed 36303227Belohlavek 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.
PubMed 35191923Belohlavek 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.
PubMed 22883307
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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. "Prague OHCA Study"
- ClinicalTrials.gov ID
- NCT01511666
- Acronym / sponsor ID
- Prague OHCA study
- Conditions
- Out-of Hospital Cardiac Arrest
- Keywords
- cardiac arrest, mechanical chest compressions, intraarrest cooling, ECLS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DSMB recommendation to stop
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- 25 Oct 2020 (actual)
- Study completion
- 25 Oct 2020 (actual)
- First posted
- 19 Jan 2012 (estimated)
- 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.
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.
Detailed description
Background: Out of hospital cardiac arrest (OHCA) has a poor outcome. Recent non-randomized study of ECLS (extracorporeal life support) in OHCA suggested further prospective multicenter studies to define population with OHCA that would benefit from ECLS.
Aim: to perform a prospective randomized multicenter clinical study comparing use of prehospital intraarrest hypothermia, mechanical chest compression device, 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.
Planned intervention: patients with witnessed OHCA without ROSC (return of spontaneous circulation) after a minimum of 5 minutes of ACLS by emergency medical service (EMS) team will be after fulfilling of inclusion/exclusion criteria for the study randomized in a 1:1 design to standard vs. hyperinvasive arm. Patients in standard arm will be further managed as per recent guidelines. In hyperinvasive arm, mechanical compression device together with intranasal cooling will be immediately instituted and patients will be transferred to cardiac center directly to cathlab under ongoing CPR. After admission to cathlab, overall status, ROSC and ECLS inclusion/exclusion criteria will be evaluated and in case of no contraindications to ECLS and no ROSC or ROSC with shock, veno-arterial ECLS will be started as soon as possible, not later than 60 minutes after cardiac arrest onset. After ECLS institution, mild hypothermia will be continued by means of ECLS cooling and immediate invasive investigation will be performed in all patients.
Standard postresuscitation care will follow.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperinvasive arm | Experimental | Device: Prehospital mechanical compressions, intraarrest cooling and in hospital ECLSHyperinvasive 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. |
| Standard arm | Active comparator | Other: Standard carePatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- OHCA of presumed non-cardiac cause
- unwitnessed collapse
- pregnancy
- sustained ROSC within 5 minutes of ACLS performed by EMS team
- conscious 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 |
|---|---|---|
| Prehospital mechanical compressions, intraarrest cooling and in hospital ECLSAlso: LUCAS, Rhinochill, ECLSECLS states for extracorporeal life support. | Device | Hyperinvasive arm |
| Standard careStandard care as per recent guidelines will be provided. | Other | Standard arm |
Primary outcome
Composite endpoint of survival with good neurological outcome (CPC 1-2).
Time frame: 6 months
2 secondary outcomes
Neurological recovery
Time frame: 30 days
Cardiac recovery
Time frame: 30 days
Results and safety
The study was stopped early (reason given: DSMB recommendation to stop). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Derived from this study: PubMed 40381979Smalcova 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.
- Derived from this study: PubMed 38627823Rob 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.
- Derived from this study: PubMed 37806620Smalcova 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.
- Derived from this study: PubMed 37574002Dusik 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.
- Derived from this study: PubMed 36303227Rob 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.
- Derived from this study: PubMed 35191923Belohlavek 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.
- Derived from this study: PubMed 22883307Belohlavek 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.
- Individual participant dataSharing planned: Undecided
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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.
Jan Belohlavek principal investigator
General University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehospital mechanical compressions, intraarrest cooling and in hospital ECLS in people with Out-of Hospital Cardiac Arrest, run by Charles University, Czech Republic at 1 site in Czechia.
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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. 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 was stopped early (reason given: DSMB recommendation to stop). Results are not available in the source record.
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?
Composite endpoint of survival with good neurological outcome (CPC 1-2). (time frame: 6 months). 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 NCT01511666, which also lists 7 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 15 Mar 2021.