Hyperinvasive Approach in Cardiac Arrest

Out-of Hospital Cardiac Arrest Clinical Trial

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"

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01511666
• Other study ID #: Prague OHCA study
• Status: Terminated
• Phase: N/A
• Start date: March 2013
• Est. completion date: October 25, 2020

Study information

• Verified date: March 2021
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 256
• Est. completion date: October 25, 2020
• Est. primary completion date: October 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Arrest
• Out-of Hospital Cardiac Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Device:
• Prehospital mechanical compressions, intraarrest cooling and in hospital ECLS
ECLS states for extracorporeal life support.

Other:
• Standard care
Standard care as per recent guidelines will be provided.

Locations

Country	Name	City	State
Czechia	General Teaching Hospital	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoint of survival with good neurological outcome (CPC 1-2).		6 months
Secondary	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.	30 days
Secondary	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 .	30 days