Actively Recruiting
A Randomized Controlled Study of the NEURESCUE Device as an Adjunct to Advanced Cardiac Life Support
Led by neurescue · Updated on 2025-11-17
84
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates cardiac arrest treatment by comparing standard Advanced Cardiovascular Life Support (ACLS) alone to ACLS combined with aortic balloon occlusion (ABO) using the NEURESCUE device. The study aims to evaluate the clinical safety and performance of adding ABO, an emergency method that quickly directs blood flow to the heart and brain during cardiac arrest, potentially improving outcomes. Participants are randomly assigned to one of two groups: one receiving standard ACLS treatment, which includes CPR, airway management, ventilation, and defibrillation, and the other receiving ACLS plus ABO using the NEURESCUE device. The NEURESCUE catheter is inserted via the femoral artery into the descending aorta and temporarily inflates a balloon to redirect blood flow. The NEURESCUE Assistant controls pressure-regulated inflation and deflation of the balloon during treatment. Throughout the study, cardiac rhythm and return of spontaneous circulation are closely monitored. Participants will have four visits, including a 90-day follow-up to assess outcomes. Researchers will measure resuscitation success, epinephrine use, procedures, adverse events, neurological function via CPC score, quality of life with EQ-5D, and survival. The study runs from randomization through 90 days post cardiac arrest to evaluate safety and performance.
CONDITIONS
Brief Title
A Randomized Controlled Study of the NEURESCUE Device as an Adjunct to Advanced Cardiac Life Support
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years
- Witnessed cardiac arrest
- CPR started within 7 minutes of arrest
- CPR ongoing for less than 40 minutes at enrollment
- Non-shockable heart rhythm
You will not qualify if you...
- Traumatic cardiac arrest
- Known pregnancy
- Known terminal disease
- Do-not-attempt-CPR order
- Known opposition to study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From randomization to approximately 70 minutes after randomization
Participants receive Advanced Cardiac Life Support (ACLS) with or without the NEURESCUE device for aortic balloon occlusion (ABO) during cardiac arrest treatment.
Continuous monitoring during treatment
Duration - Up to 90 days post cardiac arrest
Participants are monitored with up to 4 visits including assessments at discharge or 7 days, and a final 90-day follow-up after cardiac arrest.
4 visits including the 90-day follow-up visit
Trial Site Locations
Total: 2 locations
1
Charité - Universitätsklinikum Berlin
Berlin, Germany, 12203
Actively Recruiting
2
University Hospital Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
Research Team
M
Michael Preusch, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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