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FEMART-1 Pilot Study

RecruitingNAAges 18 Years - 70 YearsAllEmergency Medical Service, Prague
NCT07596446 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 c

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📋 Eligibility rules (as published)
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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What it tests

  • Prehospital Ultrasound-Guided Femoral Arterial Sheath Placement
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Where

1 site
EMS Prague
Prague, Czechia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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