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A prospective pilot feasibility study of prehospital ECPR in patients with refractory OHCA
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehospital extracorporeal cardiopulmonary resuscitation (ECPR) | Experimental | Prehospital ECPR will include all patients who enter the study and receive ECPR. The historical control group will consist of patients from the Prague OHCA study who received in-hospital ECPR and fulfilled all relevant inclusion and exclusion criteria for this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal cardiopulmonary resuscitation (ECPR) | Other | Prehospital extracorporeal cardiopulmonary resuscitation (ECPR) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time from collapse to ECPR | Time from collapse to start of VA ECMO flow | Time from estimated collapse to start of VA ECMO flow (estimated range: 20-100 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| All cause survival at 30-days | Kaplan Meier analysis, log-rank test | 30-days |
| Modified Rankin Scale at 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Major bleeding | Major bleeding, TIMI classification | 30-days |
| Vascular complications | Vascular complications including disections, pseudoaneurysm, closure, thrombus |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Belohlavek, MD, PhD | Contact | 420724371594 | jan.belohlavek@vfn.cz | |
| Daniel Rob, MD, PhD | Contact | 420721932067 | daniel.rob@vfn.cz |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General University Hospital in Prague | Recruiting | Prague | Czechia | 12800 | Czechia |
The datasets used and analyzed in this study will be available from the principal investigators upon reasonable request.
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| ID | Term |
|---|---|
| D058687 | Out-of-Hospital Cardiac Arrest |
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Single-arm interventional study with a historical control from Prague OHCA study
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| 30-days |
| 30-days |
| Infectious complications | Local groin infection requiring treatment or sepsis requiring treatment | 30-days |