An observational study in Endovascular Therapy, Brain Edema and Prediction Model, sponsored by Zhejiang Provincial People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-06-11.
Sponsored by Zhejiang Provincial People's Hospital · Observational
To design and validate a predictive model for malignant brain edema after endovascular thrombectomy.
Stroke is a significant global cause of death and disability. Endovascular thrombectomy (EVT) is currently the best treatment for acute large vessel occlusion stroke (ALVOS), as it can greatly reduce mortality and improve patient outcomes. However, only half of patients who undergo EVT achieve functional independence, and malignant brain edema (MBE), a severe complication, can occur after the procedure, leading to a poor prognosis. Previous studies have confirmed the effectiveness of early decompressive hemicraniectomy in reducing morbidity and mortality in patients with malignant brain edema. Therefore, identifying high-risk patients for MBE can help clinicians make appropriate triage and early intervention decisions, potentially saving patients' lives.
Predictive factors for post-ischemic stroke brain edema have been widely discussed, and reliable early predictive indicators have been identified, such as age, early consciousness disorders, baseline National Institutes of Health Stroke Scale (NIHSS), atrial fibrillation, hypertension, baseline blood glucose, and the level of reperfusion after EVT. Radiological factors, such as the Alberta Stroke Program Early CT Score (ASPECTS), collateral circulation rating of arteries, venous outflow status, CT perfusion core infarct volume, perfusion-based collateral status, and clot burden, are closely associated with the occurrence of MBE post-EVT. However, due to individual differences and multiple factors affecting MBE, a single factor cannot effectively predict MBE. Establishing a clinical risk prediction model can effectively identify high-risk populations for MBE at an early stage.
102 studies on the registry are indexed under Brain Edema; 25 are open to participants now.
This study's planned enrollment of 1,950 is above the median of 88 across 31 observational studies indexed under Brain Edema.
Browse Brain Edema studies →Zhejiang Provincial People's Hospital is the lead sponsor of 62 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study is a multicenter, prospective, observational clinical registry study, commenced on April 1, 2024, and is expected to end in June 2027. Participants were ALVOS patients undergoing EVT treatment in neurology departments from multiple stroke centers. The data from Zhejiang Provincial People's Hospital compose the model training cohort, while data from other centers serve as an independent external validation cohort. The protocol of the study has been approved by the human Ethics Committee of Zhejiang Provincial People's Hospital (KY2024058). All clinical investigations will be conducted according to the principles set in the Declaration of the Helsinki.
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Exclusion Criteria:
The occurrence of MBE
Patients developed MBE within 3 days post-EVT
Time frame: 3 days post-EVT
90 days mRS score
The follow-up mRS scores of enrolled patients at 90 days after EVT.
Time frame: 90 days after EVT
PH
Evidence of parenchymal hemorrhage (PH type) on cranial imaging at 3-5 days after EVT
Time frame: 3-5 days after EVT
PDFs hosted by the registry, ClinicalTrials.gov.
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Zhejiang Provincial People's Hospital