Hyperinvasive Approach in Cardiac Arrest
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| ClinicalTrials.gov Identifier: NCT01511666 |
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Recruitment Status :
Terminated
(DSMB recommendation to stop)
First Posted : January 19, 2012
Last Update Posted : March 15, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Out-of Hospital Cardiac Arrest | Device: Prehospital mechanical compressions, intraarrest cooling and in hospital ECLS Other: Standard care | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 256 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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" |
| Actual Study Start Date : | March 2013 |
| Actual Primary Completion Date : | October 25, 2020 |
| Actual Study Completion Date : | October 25, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Hyperinvasive arm
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.
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Device: Prehospital mechanical compressions, intraarrest cooling and in hospital ECLS
ECLS states for extracorporeal life support.
Other Names:
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Active Comparator: Standard arm
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.
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Other: Standard care
Standard care as per recent guidelines will be provided. |
- Composite endpoint of survival with good neurological outcome (CPC 1-2). [ Time Frame: 6 months ]
- Neurological recovery [ Time Frame: 30 days ]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.
- Cardiac recovery [ Time Frame: 30 days ]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 .
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511666
| Czechia | |
| General Teaching Hospital | |
| Prague, Czechia, 128 02 | |
| Principal Investigator: | Jan Belohlavek | General University Hospital |
Documents provided by Jan Belohlavek, Charles University, Czech Republic:
| Responsible Party: | Jan Belohlavek, Jan Belohlavek, MD, PhD., Consultant in Cardiology and Critical Care, Charles University, Czech Republic |
| ClinicalTrials.gov Identifier: | NCT01511666 |
| Other Study ID Numbers: |
Prague OHCA study |
| First Posted: | January 19, 2012 Key Record Dates |
| Last Update Posted: | March 15, 2021 |
| Last Verified: | March 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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cardiac arrest mechanical chest compressions intraarrest cooling ECLS |
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Heart Arrest Out-of-Hospital Cardiac Arrest Heart Diseases Cardiovascular Diseases |