A Multicenter, Randomized Controlled Clinical Trial on the Efficacy and Safety of Neuroendoscopic Hematoma Evacuation Combined With Methylprednisolone Sodium Succinate in the Treatment of Basal Ganglia Intracerebral Hemorrhage at the Early Stage.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Modified Rankin scale score (mRS)
研究概览
简要总结
The aim of this trial is to investigate whether neuroendoscopic hematoma evacuation combined with early use of methylprednisolone sodium succinate can improve the efficacy and safety in the treatment with that of simple neuroendoscopic surgery alone for patients with spontaneous basal ganglia intracerebral hemorrhage within 24 hours after the onset.
详细描述
There is still a lack of the best evidence-based reference for the treatment of basal ganglia intracerebral hemorrhage. The ENRICH trial published in 2024 demonstrated that minimally invasive hematoma evacuation might have a better clinical prognosis than standard medical treatment in patients with spontaneous intracerebral hemorrhage. However, the significant effect of the surgery might be mainly attributed to the intervention in patients with basal ganglia hemorrhage. Besides, simply relying on surgical removal of hematoma may not be sufficient to significantly improve the long-term prognosis of patients. How to effectively control secondary brain injury, reduce cerebral edema and inflammatory response is the key to improving the prognosis of patients with basal ganglia intracerebral hemorrhage. Methylprednisolone sodium succinate can reduce the disruption of the blood-brain barrier and inflammatory response in animal models of intracerebral hemorrhage, and alleviate brain injury. The results of the MARVEL trial released in 2024 showed that methylprednisolone sodium succinate has demonstrated the potential to reduce the incidence of secondary intracerebral hemorrhage (ICH) and mortality in patients with acute ischemic stroke.
This study aims to systematically evaluate the efficacy and safety of neuroendoscopic hematoma evacuation combined with the early use of methylprednisolone sodium succinate in patients with basal ganglia intracerebral hemorrhage through a multicenter, prospective, randomized controlled clinical trial. The study will compare the differences in main endpoint indicators such as functional independence, quality of life and survival rate at 3 months and 6 months after surgery between the group receiving surgical treatment combined with methylprednisolone sodium succinate and the group receiving surgical treatment alone, so as to explore the impact of different treatment strategies on the prognosis of patients with basal ganglia intracerebral hemorrhage.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 80 years old.
- •Diagnosed with spontaneous intracerebral hemorrhage (ICH) through cranial CT scan, with the bleeding site located in the basal ganglia region.
- •Calculate the hematoma volume based on the cranial CT scan. The volume should range from 30 to 80 ml, and the shift of the mid - line structure at the pineal gland level should be less than 3 mm. The formula for calculating the hematoma volume is V (cm³)=A * B * C * 1/2, where A represents the longest diameter (cm) of the largest hematoma layer in the horizontal position of the plain CT scan, B is the widest diameter (cm) of the hematoma perpendicular to A on this plane, and C is the thickness (cm) of the hematoma shown in the CT images.
- •The time from the onset of the disease to randomization should be within 24 hours. If the actual onset time is unclear, the onset time will be regarded as the time when the subject was last confirmed to be in good health.
- •The National Institutes of Health Stroke Scale (NIHSS) score should be ≥ 6 points at the time of randomization.
- •The Glasgow Coma Scale (GCS) score should range from 5 to 14 points at the time of randomization.
- •The modified Rankin Scale (mRS) score before the onset of the disease should be 0 - 1 points.
- •The patient and their legal representative should sign a written informed consent form.
排除标准
- •Hemorrhage in other locations (such as hemorrhage in infratentorial regions like the lobes, thalamus, brainstem, or cerebellum).
- •Hemorrhage caused by other reasons (for example, hemorrhage due to aneurysm, arteriovenous malformation, brain trauma, brain tumor, hemorrhagic transformation of large-area cerebral infarction, hemorrhage caused by amyloid angiopathy, hemorrhage resulting from coagulation disorders) or combined with aneurysm, arteriovenous malformation, brain trauma, brain tumor, large-area cerebral infarction, amyloid angiopathy, severe coagulation disorders.
- •Patients with intraventricular hemorrhage or those with intracerebral hemorrhage (ICH) breaking into the ventricles and considered to require external ventricular drainage.
- •A history of any parenchymal brain hemorrhage or other intracranial subarachnoid, subdural, or epidural hemorrhage and a history of relevant surgeries within the recent 30 days.
- •Patients with genetic or acquired bleeding tendencies, coagulation disorders such as deficiency of coagulation factors.
- •Platelet count < 75 × 10⁹/L.
- •Undergoing anticoagulant drug treatment with warfarin, dabigatran, or rivaroxaban, etc. within one week before enrollment, and having an international normalized ratio (INR) > 1.
- •Expected to require long-term anticoagulation and antiplatelet therapy.
- •A history of previous internal hemorrhage, with risks of gastrointestinal bleeding (such as gastrointestinal ulcers), genitourinary bleeding, or respiratory tract bleeding that has not been fully controlled.
- •Myocardial infarction occurred within the recent 30 days.
- •Known to have a high embolism risk, including patients with mechanical heart valves implanted in the body, a history of left heart thrombus, mitral stenosis accompanied by atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis. Atrial fibrillation without mitral stenosis is eligible.
- •Severe liver function impairment, with alanine aminotransferase (ALT) > 3 times the upper limit of the normal range, or aspartate aminotransferase (AST) > 3 times the upper limit of the normal range. Severe renal insufficiency, with a glomerular filtration rate < 30 ml/min/1.73 m².
- •Patients with Alzheimer's disease or mental disorders who are unable to complete the follow-up plan as required.
- •Complicated by any severe diseases that, upon evaluation, may interfere with the trial results, including diseases of the respiratory system, circulatory system, digestive system, genitourinary system, endocrine system, immune system, and hematopoietic system, etc.
- •Allergic to drugs or devices related to the operation.
- •Pregnant or lactating women, or those planning to become pregnant within one year.
- •In the terminal stage of any disease with an expected lifespan of less than 6 months.
- •Currently participating in other clinical trials or having been previously enrolled in this trial.
- •The patient or his/her legal guardian is unwilling to sign the written informed consent form.
研究组 & 干预措施
The neuroendoscopic treatment group
For patients with spontaneous basal ganglia hemorrhage within 24 hours after the onset, simple neuroendoscopic hematoma evacuation was performed.
干预措施: Simple neuroendoscopic hematoma evacuation (Procedure)
The methylprednisolone sodium succinate combined with neuroendoscopic treatment group
For patients with spontaneous basal ganglia hemorrhage within 24 hours after the onset, neuroendoscopic hematoma evacuation combined with methylprednisolone sodium succinate treatment was carried out.
干预措施: Neuroendoscopic hematoma evacuation combined with sodium methylprednisolone succinate (Combination Product)
结局指标
主要结局
Modified Rankin scale score (mRS)
时间窗: 180 days
disability level. The presence of impairments determines the transitions from mRS score 0 to mRS score 1 (symptoms) and mRS score 5 to mRS score 6 (death).
The mortality rate
时间窗: 30 days
evaluate death rate of the two treatment groups
次要结局
- Proportion of patients non-disabled (Modified Rankin scale score (mRS) 0 to 1)(180 days)
- Proportion of patients functionally independent (Modified Rankin scale score (mRS) 0 to 2)(180 days)
- Proportion of patients ambulatory or bodily needs-capable or better (Modified Rankin scale score (mRS) 0 to 3)(180 days)
- Improvement in residual hematoma volume between baseline and 7d or at discharge(7~10 days or at discharge)
- Barthel Index Score(BI)(180 days)
- European Quality Five Dimensions Five Level scale (EQ-5D-5L)(180 days)
- Mortality within 7 days randomly or at discharge(7days or at discharge)
- symptomatic intracranial rebleeding, asymptomatic intracranial rebleeding and intracranial infection(within 180 days after randomized)
- Change in National Institute of Health stroke scale (NIHSS) score between baseline and 7~10d or at discharge(7~10 days or at discharge)
- Change in Glasgow Coma Scale(GCS) between baseline and 7~10d or at discharge(7~10 days or at discharge)
- severe adverse events(within 180 days after randomization)
- symptomatic intracranial rebleeding, asymptomatic intracranial rebleeding and intracranial infection(within 30 days after randomized)
研究者
Yong Jiang
Prof.
The Affiliated Hospital Of Southwest Medical University