Supplemental Material for: The minimally invasive soft channel brain hemorrhage evacuation for acute basal ganglia hemorrhage - small hemorrhage evacuation (MIRACLE-S) trial: rationale, design and progress
Year: 2026
Type: supplementary-materials
Abstract: Introduction: Acute spontaneous intracerebral hemorrhage (ICH) is a devastating type of stroke, where patients with small and large hematomas generally have favorable and poor outcomes, respectively, regardless of treatment. For patients with moderate-volume (20 to 30 mL) deep hemispheric hematomas, however, clinical equipoise remains as the randomized evidence for surgery is limited. Methods: The minimally invasive soft-channel brain hemorrhage evacuation for acute basal ganglia hemorrhage – small hemorrhage evacuation (MIRACLE-S) trial is a multicenter, prospective, randomized, open-label, blinded-endpoint assessed trial conducted in China. Eligibility criteria are adult patients aged 18 to 80 years with spontaneous basal ganglionic ICH with a hematoma volume of 20 to 30 mL, Glasgow coma scale score 9 to 14, premorbid modified Rankin scale score 0 to 1, and systolic blood pressure <140 mmHg enrolled within 48 hours of symptom onset. Patients are randomized (1:1) to soft-channel minimally invasive surgery (scMIS; stereotactic aspiration with catheter-based urokinase thrombolysis) or guideline-based conservative medical management. The primary efficacy outcome is a hierarchical composite endpoint of death, disability (mRS scores 3 to 5), rehospitalization, and poor health-related quality of life assessed at 180 days and analyzed using a win-ratio approach. Safety outcomes include mortality, rebleeding (including puncture-tract hemorrhage), and infection within 30 days. Results: Recruitment started January 1, 2025. As of February 27, 2026, 148 patients have been randomized at 34 active sites. The required sample size of 420 to detect a win-ratio effect size of 1.62 (P_tie=0.05), is expected to be achieved in 2028. Conclusion: MIRACLE-S will clarify whether aspiration-based scMIS improves recovery as compared with best medical management in patients with moderate-volume basal ganglionic ICH, which is a common clinical burden in China and other regions with high rates of ICH.
Source: Figshare
Authors: figshare admin karger, Xia Wang, Junfa Zeng, Lei Luo, Hetao Bian, Zhenchuan Liu, Zhongxiang Xie, Bing Li, Fuchun Zhao, Feng He, Xiaojie Song, Xinghua Chen, Shengjie Li, Chuanjiang Huang, Chigang Du, Qihao Wang, Lili Song, Craig S. Anderson, Fengyuan Che, Tao Xin, Xunming Ji, MIRACLE-S Investigators
Institution: Karger Publishers (Switzerland)
Language: English
Subfield: Clinical Neurology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7203764643