Neuroprotective Effect of Remote Ischemic Post-conditioning in Out-of-hospital Cardiac Arrest (NCT06473207) | Clinical Trial Compass
RecruitingNot Applicable
Neuroprotective Effect of Remote Ischemic Post-conditioning in Out-of-hospital Cardiac Arrest
France48 participantsStarted 2025-01-11
Plain-language summary
Patients admitted to intensive care unit (ICU) following an out-of-hospital cardiac arrest (OHCA) have a high morbidity and mortality rate, primarily due to ischemia-reperfusion (I/R) syndrome leading to anoxic-ischemic brain injury. Despite current recommended advanced life support therapies, no specific treatment or procedure has yet been shown to improve the neurological outcome of such patients.
Remote ischemic post-conditioning (RIPOST) which usually consists of applying brief and repeated cycles of ischemia alternating with reperfusion by inflating and deflating a blood pressure cuff or a pneumatic tourniquet placed around a limb, is a promising strategy to protect organs against I/R injury, including brain. Regarding cardiac arrest, pre-clinical studies have demonstrated an improvement in neurological outcome in animal subjects treated with RIPOST after cardiopulmonary resuscitation.
The aim of our study is to demonstrate the benefit of early RIPOST in OHCA patients in reducing neurological injury and organ failure related to I/R syndrome.
Who can participate
Age range
18 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:
* Out-of-hospital cardiac arrest with stable return of spontaneous circulation (ROSC \> 20 minutes)
* Patient receiving invasive mechanical ventilation for coma (Glasgow score \< 8)
* Availability of a lower limb without intravenous infusion or tension cuff positioned on it
* Randomization and application of the first session of the tested procedure within 4 hours after ROSC
* Consent of a next-of-kin or inclusion in emergency procedure
Exclusion criteria :
* Age \< 18 y.o or pregnancy
* Patient unable to walk without assistance, unable to support himself properly without assistance, bedridden, incontinent and requiring nursing constant attention and care (corresponding to a mRS equal to 4 or 5)
* Interval between cardiac arrest and ROSC (no flow + low flow) estimated \> 60 minutes
* Unwitnessed cardiac arrest with asystole as first rhythm
* In-hospital cardiac arrest
* Refractory cardiac arrest (no ROSC considered as stable)
* Cardiac arrest from traumatic, hemorrhage, stroke or hanging supposed origin
* Mean arterial pressure \< 65mmHg persisting despite appropriate vascular filling and vasopressor and/or inotropic support
* Active uncontrolled bleeding
* Contraindication or not possible to use a pneumatic tourniquet on none of the two lower limbs (amputations, intravenous infusion positioned on both lower limbs, tourniquet size incompatible with patient morphology)
* Implementation of extracorporeal arteriovenous circulation for refractory cardiac ar…
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.
1This trial measures a protein called neurofilament light chain in the blood as a sign of brain injury after cardiac arrest — can you explain what that marker tells us about my loved one's brain recovery, and whether tracking it changes how they would be treated?
2The procedure being studied is called remote ischemic post-conditioning, which involves briefly cutting off and restoring blood flow to a limb after cardiac arrest — can you walk me through exactly how that's done and what risks it might carry for someone who just survived a cardiac arrest?
3Since this trial is listed as 'Phase NA,' it seems to be more of an observational or early feasibility study rather than a late-phase treatment trial — does that mean the main goal is to gather data rather than to directly improve my loved one's outcome, and how should that affect our decision?
4Would participating in this trial interfere with or delay any of the standard post-cardiac arrest care my loved one would normally receive, such as targeted temperature management or other critical care protocols?
5Are there patients who would be better suited for this trial than others — for example, are there specific time windows after the cardiac arrest, or medical conditions, that would make participation safer or less appropriate to discuss with you?
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
Neurofilament light chain (NFL) blood level evolution between 6 and 72 hours after cardiac arrest occurrence
Timeframe: 72 hours after out-of-hospital cardiac arrest occurrence
Trial details
NCT IDNCT06473207
SponsorCentre Hospitalier Intercommunal de Toulon La Seyne sur Mer