Predicting brain swelling after stroke treatment
Early Identification of Malignant Brain Edema in laRge Artery oCclusive Stroke After Endovascular Therapy (EMBRACE Study)
This study is testing a new way to predict which stroke patients are at risk for dangerous brain swelling after a specific treatment to help doctors make better decisions for their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1950 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Zhejiang Provincial People's Hospital Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06451887 on ClinicalTrials.gov |
What this trial studies
This study aims to design and validate a predictive model for malignant brain edema (MBE) following endovascular thrombectomy (EVT) in patients with acute large vessel occlusion stroke. By identifying high-risk patients for MBE, clinicians can make informed decisions regarding triage and early interventions, potentially improving patient outcomes. The study will analyze various predictive factors, including clinical and radiological indicators, to enhance the accuracy of early predictions for MBE. The ultimate goal is to reduce morbidity and mortality associated with this severe complication of stroke treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have experienced an ischemic stroke and are undergoing endovascular thrombectomy within 24 hours of symptom onset.
Not a fit: Patients with posterior circulation occlusion or those with severe comorbidities that limit their expected survival may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient outcomes by enabling timely interventions for those at high risk of malignant brain edema.
How similar studies have performed: Previous studies have shown promise in identifying predictive factors for malignant brain edema, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * (1)Age \> 18 years old; (2)Onset of stroke to hospital admission \< 24 hours; (3)Admission with a head CT scan ruling out hemorrhage; (4)Patients undergoing CT perfusion scan before treatment; (5)Confirmation of internal carotid artery (ICA) or middle cerebral artery (MCA) occlusion or tandem occlusion by Digital Subtraction Angiography (DSA) and subsequent EVT; (6)complete 3-months follow-up. Exclusion Criteria: * (1)Poor quality of preoperative CT perfusion imaging; (2)Posterior circulation occlusion or isolated anterior cerebral artery occlusion; (3)Presence of other severe diseases such as malignant tumors, severe organ failure, or other life-threatening conditions with an expected survival period of less than 90 days; (4)Incomplete imaging and clinical data.
Where this trial is running
Hangzhou, Zhejiang
- Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Sheng Zhang
- Email: zhangsheng@hmc.edu.cn
- Phone: 18758188313
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.