No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Emergency Medical Service, Prague · Government
Who this trial is looking for
This trial is looking for patients who have experienced a sudden cardiac arrest outside of the hospital. Participants will receive a special treatment to help monitor their heart and blood pressure in emergency situations.
Are You a Good Fit for This Trial?
You may be able to join if
I have had a non-traumatic out-of-hospital cardiac arrest.
I am between 18 and 70 years old.
I had effective CPR provided by bystanders.
My initial heart rhythm was either ventricular fibrillation or pulseless ventricular tachycardia.
I had a return of spontaneous circulation after the cardiac arrest.
You may not be able to join if
I have trauma as the probable cause of my cardiac arrest.
I have a severe health condition that I cannot recover from.
I have a do-not-resuscitate (DNR) status.
I have severe neurological disability.
I have known severe peripheral arterial disease.
I am suspected to have a pulmonary embolism.
I have severe thrombocytopenia.
I am morbidly obese.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The FEMART-1 Pilot Study is focused on evaluating the feasibility, safety, and procedural timing of prehospital femoral arterial sheath placement in patients with non-traumatic out-of-hospital cardiac arrest (OHCA), both during ongoing cardiopulmonary resuscitation and after return of spontaneous circulation (ROSC).
The primary objective of the study is to enable invasive arterial blood pressure …
The FEMART-1 Pilot Study is focused on evaluating the feasibility, safety, and procedural timing of prehospital femoral arterial sheath placement in patients with non-traumatic out-of-hospital cardiac arrest (OHCA), both during ongoing cardiopulmonary resuscitation and after return of spontaneous circulation (ROSC).
The primary objective of the study is to enable invasive arterial blood pressure monitoring for targeted and continuous hemodynamic management using vasopressor therapy in the prehospital setting. The study evaluates the feasibility, safety, and procedural performance of invasive arterial monitoring with the aim of improving assessment of the patient's hemodynamic status and enabling more accurate titration of vasopressor support. This approach may reduce episodes of hypotension and decrease the risk of recurrent cardiac arrest while allowing safer transport to specialized cardiac arrest centers.
Femoral arterial access enables more precise monitoring of perfusion pressure, targeted vasopressor titration, and early recognition of impending circulatory collapse. The intervention may contribute to improved early organ perfusion and could be associated with more favorable neurological and overall clinical outcomes after cardiac arrest. In accordance with the ERC Guidelines 2025, which emphasize active hemodynamic optimization after ROSC and acknowledge the potential role of invasive arterial pressure monitoring during ongoing resuscitation, the study evaluates not only feasibility, safety, and procedural timing, but also the potential clinical benefit of continuous hemodynamic-guided management in the prehospital phase, including (1) early identification of hypotension, (2) targeted vasopressor administration, and (3) prevention of re-arrest.
The study is conducted by the Prague Air Rescue Service Kryštof 01 (Prague Emergency Medical Services) in collaboration with the Central Bohemian Emergency Medical Service, the Second Department of Internal Medicine - Cardiology and Angiology of the General University Hospital in Prague and First Faculty of Medicine, Charles University, and the Department of Anesthesiology, Resuscitation and Intensive Care Medicine of the General University Hospital in Prague and First Faculty of Medicine, Charles University.
FEMART-1 is designed as a prospective pilot study without external funding.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
\* Non-traumatic out-of-hospital cardiac arrest (OHCA).
Patients meeting criteria for one of the following clinical scenarios:
Group A - ECPR-like group:
* Refractory cardiac arrest, including cardiac arrest occurring in the presence of the EMS crew.
* Age 18-70 years.
* Effe…
Inclusion Criteria:
\* Non-traumatic out-of-hospital cardiac arrest (OHCA).
Patients meeting criteria for one of the following clinical scenarios:
Group A - ECPR-like group:
* Refractory cardiac arrest, including cardiac arrest occurring in the presence of the EMS crew.
* Age 18-70 years.
* Effective bystander cardiopulmonary resuscitation.
* Initial rhythm of ventricular fibrillation (VF), pulseless ventricular tachycardia (pVT), or pulseless electrical activity (PEA).
Group B - post-ROSC group:
* Return of spontaneous circulation (ROSC) after non-traumatic OHCA.
* Age 18-70 years.
Exclusion Criteria:
* Trauma as the probable primary cause of cardiac arrest.
* Known severe comorbidity, including:
* terminal stage of incurable disease (advanced malignancy, advanced dementia, terminal pulmonary disease, terminal heart failure, or palliative care status),
* established do-not-resuscitate (DNR) status,
* severe pre-existing neurological disability (CPC 3 or CPC 4),
* known severe peripheral arterial disease or known occlusion of lower limb arteries,
* suspected pulmonary embolism with indication for thrombolytic therapy,
* known severe hematological disease associated with severe thrombocytopenia,
* morbid obesity.
* Known or suspected pregnancy.
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