Target-directed Management of Cerebral Oxygenation in Patients After Receiving ECPR (NCT06711016) | Clinical Trial Compass
RecruitingNot Applicable
Target-directed Management of Cerebral Oxygenation in Patients After Receiving ECPR
China654 participantsStarted 2025-04-22
Plain-language summary
Neurological injury remains an important cause of morbidity and mortality in patients with ECPR. At present, the results of three prospective randomized controlled studies on ECPR are inconsistent, and it is inconclusive whether ECPR can improve the neurological outcomes of patients with refractory cardiac arrest. Several study found that extracorporeal membrane oxygenation nonsurvivors can lead toacute brain injury.Further research with a systematic neurologic monitoring is necessary to define the timing of acute brain injury in patients with extracorporeal membrane oxygenation.Moreover, brain injury that occurs during extracorporeal membrane oxygenation therapy is not easy to detect in time because of the use of analgesics, sedatives, and muscle relaxants. Surprisingly, little attention has been paid to the role of cerebral perfusion and oxygenation. Moreover,the features of cerebrovascular pathophysiology and optimal management strategies are still vague.
Therefore multimodal neuromonitoring may be a valuable tool for detecting brain injury in patients with extracorporeal membrane oxygenation and providing early intervention guidance.
Multimodal neuromonitoring, integrating tools such as near-infrared spectroscopy (NIRS), transcranial Doppler, and continuous electroencephalography, may enable early detection of brain injury and guide targeted interventions.
Hypothesis: Multimodal neuromonitoring combined with a standard care management will increase the proportion of patients achieving survival with favorable neurological outcome (Cerebral Performance Category \[CPC\] 1-2) at 30 days compared with standard care without protocolized neuromonitoring.
Primary Objective: To test whether a multimodal neuromonitoring strategy improves 30-day survival with favorable neurological outcome (CPC 1-2) in adult patients with refractory cardiac arrest treated with ECPR.
Who can participate
Age range
18 Years – 75 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
. 18-75 years old
. Witnessed in-hospital or out-of-hospital cardiac arrest
. Patients who did not achieve return of spontaneous circulation (ROSC) after 15 minutes of conventional cardiopulmonary resuscitation (CPR), or whose ROSC cannot be maintained, and who received ECPR
. Time from cardiac arrest to initiation of CPR \< 10 minutes
. The cause of cardiac arrest is expected to be reversible (e.g., hypothermia, acute myocardial infarction/myocardial ischemia, malignant arrhythmia, pulmonary embolism, electrolyte abnormalities, hypoxia, anaphylactic shock, hemorrhage/hypovolemia, drug poisoning, electric shock, etc.)
Exclusion criteria
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 is specifically for patients who have received ECPR — extracorporeal CPR — after cardiac arrest, so can you help me understand whether that applies to our situation and whether my loved one would even be considered for something like this?
2The trial is targeting cerebral oxygenation levels after cardiac arrest, which means it involves actively managing blood flow to the brain — what does that actually involve in practice, and are there any risks to adjusting those targets compared to standard care?
3The primary outcome is measured at 30 days using the CPC neurological scale — what does a 'favorable' score of 1 or 2 actually mean for quality of life and function, and is 30 days enough time to know how someone is really recovering?
4Since this trial has no listed phase, which suggests it may be an early or exploratory study, how confident are you in the current evidence behind targeting cerebral oxygenation this way, and how does that compare to what would happen under standard post-cardiac arrest care?
5Given that ECPR itself is already an intensive intervention, is enrolling in an additional management trial something that would add meaningful burden or complexity to care, and would there be any situations where it might be better to focus on standard recovery first?
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
Favorable neurological outcome (CPC scale 1-2) at 30 days
. Participants with active gastrointestinal bleeding or other conditions with contraindications to anticoagulation
. Pregnancy
. Severe trauma
. Cerebral Performance Category (CPC) score \> 2 before cardiac arrest, or acute cerebrovascular disease (e.g., suspected or confirmed acute stroke, subarachnoid hemorrhage, etc.)
. Terminal diseases, such as malignant tumors, end-stage liver and kidney diseases, severe heart failure (NYHA class III or IV), severe COPD (GOLD class III or IV), etc.
. Transfer time from cardiac arrest to extracorporeal membrane oxygenation (ECMO) \> 90 minutes
. Previous history of bilateral femoral artery bypass grafting or artificial vascular replacement, unsuitable for ECMO catheterization