Robotic Assisted Evacuation of Subacute and Chronic Supratentorial Deep Hypertensive Intracerebral Hemorrhage for Accelerating Functional Rehabilitation (RESCUE-CHAIN): a Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 428
- 主要终点
- modified Rankin Scale (mRS) 0-2
研究概览
简要总结
Robotic Assisted Evacuation of Subacute and Chronic Supratentorial Deep Hypertensive Intracerebral Hemorrhage for Accelerating Functional Rehabilitation (RESCUE-CHAIN): a Multi-center Randomized Controlled Trial
详细描述
Background: Hypertensive intracerebral hemorrhage (HICH) is a devastating neurological disorder with high mortality and disability rates. Secondary injury following HICH may worsen motor function rehabilitation in subacute and chronic hematoma. Hematoma evacuation has the potential to reduce mass effect and mitigate the neurotoxic effects. A per-protocol analysis identified a significant functional improvement in patients with minimally invasive surgery with thrombolysis achieving end of treatment (EOT) goal ≤ 15mL. However, no surgical management of stabilized subacute or chronic HICH have been reported before. Therefore, we design this study in which we hypothesize this robotic assisted approach to hematoma EOT goal ≤ 15mL would accelerate functional rehabilitation in subacute and chronic HICH patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
modified Rankin Scale (mRS) 0-2
时间窗: 180 days after surgery
The modified Rankin Scale (mRS) is a single item, global outcomes rating scale for patients post-stroke. It is used to categorize level of functional independence with reference to pre-stroke activities rather than on observed performance of a specific task.
次要结局
- modified Rankin Scale (mRS) 0-1(180 days after surgery)
- Extended Glasgow Outcome Scale (eGOS)(at 90- and 180-days after surgery.)
- Barthel Index for Activities of Daily Living (ADL-BI)(at 90- and 180-days after surgery.)
- between-group shift analysis in the mRS distribution(180 days after surgery)
- Motor Assessment Scale (MAS)(at 90- and 180-days after surgery.)
- Evacuation rate of HICH(at the first day after procedure, 30 days and 180 days during the follow-up period.)
- Fugl-Meyer Assessment (FMA)(at 90- and 180-days after surgery.)
- NIH Stroke Scale（NIHSS）(at 90- and 180-days after surgery.)
研究者
Hou Lijun
Professor
Shanghai Changzheng Hospital