ON-SCENE Initiation of Extracorporeal CardioPulmonary Resuscitation During Refractory Out-of-Hosp… (NCT04620070) | Clinical Trial Compass
CompletedNot Applicable
ON-SCENE Initiation of Extracorporeal CardioPulmonary Resuscitation During Refractory Out-of-Hospital Cardiac Arrest
Netherlands221 participantsStarted 2021-10-15
Plain-language summary
Hypothesis: Implantation of on-scene ECPR by the HEMS teams in patients with sustained out-of-hospital cardiac arrest, results in the rapid return of circulation and, thus, improved survival and less neurological impairment, which is associated with lower health care costs.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \- Age between 18 and 50 years, known or as estimated at inclusion by the HEMS physician.
* Witnessed arrest (last seen well \<5 min), OR signs of life (gasping, movement)
* Initial rhyme is VT/VF OR Suspected of having a pulmonary embolism
* Refractory cardiac arrest lasting longer than 20 minutes and shorter than 45 min
If age is not exactly known at inclusion and is estimated by the HEMS physician between 18 and 50 years but finally the patient appears to be younger or older, the patient will not be excluded.
Exclusion Criteria:
* \- CO2 et\<1.2 kPa (10 mmHg) during CPR
* No clear echographic visualisation of either the femoral artery or the femoral vein.
* Expected time from collapse to arrival at an ECPR center with a direct available ECPR team is less than 30 min.
The following patients will be withdrawn after initial inclusion as soon as the following information becomes available:
* Known malignancy
* Known intracranial haemorrhage/ischemia \<6 weeks
* Care dependent for daily activities before arrest
* Patients with a "do not resuscitate" order, which was not known at time of the arrest.
* Refusal of deferred consent by the next of kin or by the patient himself to use the data. Deferred consent will not be asked to relatives of patients who die in scene, but are included in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hospital Survival
Timeframe: Hospital discharge (on average 6 weeks)