Extracorporeal Cardiopulmonary Resuscitation, Out of Hospital Cardiac Arrest
Conditions
Keywords
Cardiac arrest, ECPR, ECMO, Prehospital
Brief summary
A prospective pilot feasibility study of prehospital ECPR in patients with refractory OHCA
Detailed description
The aim of this pilot prospective study is to assess the feasibility and effectiveness of a prehospital extracorporeal cardiopulmonary resuscitation (ECPR) system for refractory out-of-hospital cardiac arrest (OHCA) in Prague, compared to a historical cohort of in-hospital ECPR recipients from the Prague OHCA trial.
Interventions
Prehospital extracorporeal cardiopulmonary resuscitation (ECPR)
Sponsors
General University Hospital, Prague
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-arm interventional study with a historical control from Prague OHCA study
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Estimated age 18-70 years * Refractory out-of-hospital cardiac arrest (3 unsuccessful defibrillations and/or at least 10 minutes of resuscitation in case of pulseless electrical activity) * Witnessed cardiac arrest * ECPR team available * ECPR team alert within 20 minutes from the emergency call
Exclusion criteria
* Unwitnessed cardiac arrest * Asystole * ETCO2 less than 10 mmHg upon ECPR team arrival * Known limitations of intensive care (Do Not Resuscitate - DNR status) * Known severe neurological impairment prior to cardiac arrest (mRS 4-6) * Suspected or known pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time from collapse to ECPR | Time from estimated collapse to start of VA ECMO flow (estimated range: 20-100 minutes) | Time from collapse to start of VA ECMO flow |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All cause survival at 30-days | 30-days | Kaplan Meier analysis, log-rank test |
| Modified Rankin Scale at 30-days | 30-days | Modified Rankin Scale (mRS) at 30 days: mRS 0-3 is considered a good outcome, and mRS 4-6 is considered a poor outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Major bleeding | 30-days | Major bleeding, TIMI classification |
| Vascular complications | 30-days | Vascular complications including disections, pseudoaneurysm, closure, thrombus |
| Infectious complications | 30-days | Local groin infection requiring treatment or sepsis requiring treatment |
Countries
Czechia
Contacts
Primary ContactJan Belohlavek, MD, PhD
Backup ContactDaniel Rob, MD, PhD
Outcome results
None listed