Clinical Trial

Target-directed Management of Cerebral Oxygenation in Patients After Receiving ECPR

Study acronym: TDMCO-ECPR
Recruiting
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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.
Trial Details
NCT Number NCT06711016
Lead Sponsor Qilu Hospital of Shandong University
Collaborators: China-Japan Friendship Hospital, The First Affiliated Hospital of Zhengzhou University, Second Affiliated Hospital of Guangzhou Medical University, Second Affiliated Hospital of Zhengzhou University, Guangdong Provincial People's Hospital, Hunan Provincial People's Hospital, Jiangsu Provincial People's Hospital, The Affiliated Hospital of Qingdao University, Second Affiliated Hospital, School of Medicine, Zhejiang University, Beijing Anzhen Hospital, The Second Hospital University of South China, The Affiliated Hospital of Xuzhou Medical University, Heze Municipal Hospital, Shenzhen People's Hospital, The Second Medical College of Jinan University, Liaocheng People's Hospital, Jining First People's Hospital, Weifang People's Hospital, The First People's Hospital of Lianyungang, Huai'an First People's Hospital
Conditions Cardiac Arrest
Enrollment 654 participants
Start Date 2025-04-22
Primary Completion 2028-05-30 (estimated)
Study Completion 2028-07-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-08