Refractory Cardiac ArresteCPR on SiteNCT07155772
Feasibility Study on a Prehospital Extracorporeal CardioPulmonary Resuscitation in the Pavia's Province.
A study testing Extracorporeal CardioPulmonary Resuscitation (eCPR) in people with Refractory Cardiac Arrest, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
This is a single Center interventional study, assessing the feasibility of a complex treatment strategy where an in-hospital standard care process is applied in an out-of-hospital cardiac arrest. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Refractory Cardiac Arrest
- What is being tested?
- Extracorporeal CardioPulmonary Resuscitation (eCPR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 26 Nov 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- out-of-hospital cardiac arrest occurred in Pavia province
- the age of the patient is between 18 and 70
- witnessed cardiac arrest
- CPR started within 5 minutes of the patient's collapse or presence of gasping at the arrival of the ACLS team
- eCPR team arrived within 60 minutes of the patient's collapse
- etCO2 ≥ 10 mmHg
- mechanical chest compression is ongoing
- refractory cardiac arrest after at least 15 minutes of ACLS
Who cannot join
- Modified Rankin Scale (mRS) ≥ 3
- Advanced COPD or other advanced pulmonary illness
- End-stage or metastatic neoplasm
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, 27100
Alessandra Palo, MD, +39 0382 50 3711, a.palo@smatteo.pv.it
About this study
Official title: Feasibility Study on a Prehospital Extracorporeal CardioPulmonary Resuscitation in the Pavia's Province. An Interventional Study on Complex Treatment Strategy
This is a single Center interventional study, assessing the feasibility of a complex treatment strategy where an in-hospital standard care process is applied in an out-of-hospital cardiac arrest.
The objective of this study is to investigate the feasibility of a prehospital eCPR program in the context of the Pavia province in order to reduce the time from cardiac arrest to organ reperfusion with thefarthest aim of improving survival and good neurologic outcomes of patient victims of refractory cardiac arrest.
- Conditions
- Refractory Cardiac Arrest
- Being tested
- Extracorporeal CardioPulmonary Resuscitation (eCPR)
- Keywords
- cardiac arrest
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal CardioPulmonary Resuscitation (eCPR)Procedure or surgery
The intervention of this study consists of moving the current eCPR program out of the hospital to reduce the time from collapse to ECMO flow (low-flow time).
| Study group | Role | What they receive |
|---|---|---|
| Patients with refractory cardiac arrest who receive extracorporeal cardiopulmonary resuscitation | Experimental | Not described Receives: Procedure: Extracorporeal CardioPulmonary Resuscitation (eCPR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of successful eCPR placed in prehospital settings over patients that meet inclusion criteria
Successful cannulation is described as maintaining an ECMO circulatory flow of 40 ml/kg/min or more for at least 5 minutes.
Measured: up to 12 months
Secondary outcomes (3)
Cause of cannulation failure
Measured: up to 12 months
Proportion of cannulation feasibility according to the implant site
Measured: up to 12 months
Evaluation of eCPR Team Performance
Evaluation of eCPR Team Performance to better design a definitive institutional eCPR program
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start26 Nov 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandra Palo, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155772
- Sponsor's protocol ID
- eCPR on Site
- Acronym
- eCPR on Site
- Status last verified
- Feb 2025
- First submitted
- 7 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study on a Prehospital Extracorporeal CardioPulmonary Resuscitation in the Pavia's Province. An Interventional Study on Complex Treatment Strategy
- ClinicalTrials.gov ID
- NCT07155772
- Acronym / sponsor ID
- eCPR on Site / eCPR on Site
- Conditions
- Refractory Cardiac Arrest
- Keywords
- cardiac arrest
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 4 Sep 2025 (actual)
- 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.
This is a single Center interventional study, assessing the feasibility of a complex treatment strategy where an in-hospital standard care process is applied in an out-of-hospital cardiac arrest.
The objective of this study is to investigate the feasibility of a prehospital eCPR program in the context of the Pavia province in order to reduce the time from cardiac arrest to organ reperfusion with thefarthest aim of improving survival and good neurologic outcomes of patient victims of refractory cardiac arrest.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with refractory cardiac arrest who receive extracorporeal cardiopulmonary resuscitation | Experimental | Procedure: Extracorporeal CardioPulmonary Resuscitation (eCPR) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- out-of-hospital cardiac arrest occurred in Pavia province
- the age of the patient is between 18 and 70
- witnessed cardiac arrest
- CPR started within 5 minutes of the patient's collapse or presence of gasping at the arrival of the ACLS team
- eCPR team arrived within 60 minutes of the patient's collapse
Key exclusion criteria (3 listed)
- Modified Rankin Scale (mRS) ≥ 3
- Advanced COPD or other advanced pulmonary illness
- End-stage or metastatic neoplasm
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 |
|---|---|---|
| Extracorporeal CardioPulmonary Resuscitation (eCPR)The intervention of this study consists of moving the current eCPR program out of the hospital to reduce the time from collapse to ECMO flow (low-flow time). | Procedure or surgery | Patients with refractory cardiac arrest who receive extracorporeal cardiopulmonary resuscitation |
Primary outcome
number of successful eCPR placed in prehospital settings over patients that meet inclusion criteria
Time frame: up to 12 months
Successful cannulation is described as maintaining an ECMO circulatory flow of 40 ml/kg/min or more for at least 5 minutes.
3 secondary outcomes
Cause of cannulation failure
Time frame: up to 12 months
Proportion of cannulation feasibility according to the implant site
Time frame: up to 12 months
Evaluation of eCPR Team Performance
Time frame: up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal CardioPulmonary Resuscitation (eCPR) in people with Refractory Cardiac Arrest, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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 8 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 4 Sep 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandra Palo, MD (+39 0382 50 3711, a.palo@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of successful eCPR placed in prehospital settings over patients that meet inclusion criteria (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2025.