Target-directed management of brain oxygenation after ECPR
Official title: Efficacy and Safety of Target-directed Management of Cerebral Oxygenation in Patients Undergoing Extracorporeal Cardiopulmonary Resuscitation: A Multicenter, Pragmatic, Randomized, Controlled Clinical Trial
Run by Qilu Hospital of Shandong University · NCT06711016 · Data updated 2026-11-12
This study tests whether monitoring cerebral oxygen levels during ECPR can help guide care to improve brain outcomes after cardiac arrest.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 654 (estimated) |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Locations | 2 sites (Jinan, Shandong and 1 other locations) |
| Status | Recruiting |
| Started | April 22, 2025 |
| Main results expected | May 30, 2028 |
| Study ends | July 30, 2028 |
| Registry record updated | June 8, 2026 |
| Trial ID | NCT06711016 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 who have had a cardiac arrest (in- or out-of-hospital) and received ECPR after failing ROSC or losing hemodynamic stability.
✕Probably not a fit
Patients without reversible causes of arrest or with exclusion criteria such as active bleeding or severe preexisting brain injury may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study looks at patients who have undergone extracorporeal membrane oxygenation for cardiac arrest. It uses continuous cerebral oxygenation monitoring to categorize rSO2 readings and compare standard ECPR monitoring with a blinded monitoring approach. The goal is to see if targeted brain oxygenation management can influence neurological outcomes in patients with refractory arrests. The protocol emphasizes multimodal neuromonitoring and aims to clarify the timing and nature of acute brain injury during ECMO support. Results will inform best practices for protecting brain perfusion and oxygenation during ECPR.
Why it matters
Potential benefit: If successful, patients may have better neurological outcomes and reduced brain injury after ECPR.
How similar studies have gone: Previous randomized studies on ECPR have shown inconsistent results; this trial uses continuous brain oxygen monitoring to address a gap and explore potential benefits.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: 1. 18-75 years old 2. Witnessed in-hospital or out-of-hospital cardiac arrest 3. 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 4. Time from cardiac arrest to initiation of CPR \< 10 minutes 5. 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: 1. Aortic dissection 2. Participants with active gastrointestinal bleeding or other conditions with contraindications to anticoagulation 3. Pregnancy 4. Severe trauma 5. Cerebral Performance Category (CPC) score \> 2 before cardiac arrest, or acute cerebrovascular disease (e.g., suspected or confirmed acute stroke, subarachnoid hemorrhage, etc.) 6. 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. 7. Transfer time from cardiac arrest to extracorporeal membrane oxygenation (ECMO) \> 90 minutes 8. Previous history of bilateral femoral artery bypass grafting or artificial vascular replacement, unsuitable for ECMO catheterization
Where it's running
-
Qilu hospital
Jinan, Shandong, China Recruiting -
Qilu Hospital
Jinan, Shandong, China Not yet recruiting
Study contacts
- Study coordinator: Xianfei Ji, MD. PhD
- Email: qlyyjxf@163.com
- Phone: 0086-531-82165072
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.