Aneurysmal Subarachnoid Hemorrhage Treatment Based on Intraventricular Intracranial Pressure Monitoring: A Prospective, Multicenter, Randomized and Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 372
- 试验地点
- 1
- 主要终点
- Favourable functional outcome at 3 months
研究概览
简要总结
ASTIM is a multicenter, prospective, randomised, blinded end-point assessed trial, to investigate the efficacy and safety of treatment based on intracranial pressure monitoring in improving the prognosis of patients with aneurysmal subarachnoid hemorrhage.
详细描述
Subarachnoid hemorrhage (SAH) is a severe type of cerebral hemorrhage, characterized by high mortality and disability rates. Approximately 85% of SAH cases are caused by ruptured intracranial aneurysms and are classified as aneurysmal SAH (aSAH). Improving the prognosis of patients with aSAH has become a pressing and significant issue.
The rupture of an aneurysm results in a significant amount of blood entering the subarachnoid space, triggering an increase in intracranial pressure (ICP). Elevated ICP can impair cerebral perfusion and contribute to secondary brain injury and poor functional outcomes. A systematic review and meta-analysis found that the incidence rate of elevated ICP (ICP >20 mmHg) in patients with aSAH was 70.69%, with elevated ICP being more common in patients with higher disease severity grades, including higher Hunt-Hess, WFNS, or modified Fisher grades.
Intraventricular ICP monitoring provides continuous, real-time quantitative ICP data and may facilitate a stepwise ICP-lowering strategy and goal-directed management based on quantitative ICP values. However, the role of continuous ICP monitoring and protocolized ICP-targeted management in aSAH remains uncertain, and high-quality randomized evidence remains limited. Given this evidence gap, this study was designed to determine whether a structured management strategy guided by continuous intraventricular ICP monitoring improves functional outcomes in patients with aSAH compared with standard care, and to assess the safety of this management strategy.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definite diagnosis of aSAH: presence of SAH symptoms confirmed by CT, with rupture of an intracranial aneurysm identified by CTA or DSA. The ruptured aneurysm is scheduled for definitive treatment (clipping or endovascular therapy) within 72 hours of onset.
- •Age ≥ 18 years.
- •Symptom onset within 72 hours.
- •Hunt-Hess grade 2-4 and modified Fisher grade 2-4 on CT imaging.
- •Written informed consent obtained from the participant or legal representative.
排除标准
- •Pregnancy or lactation;
- •Bilateral fixed dilated pupils on admission;
- •Malignancy, bleeding disorders, or other severe systemic comorbidities, including chronic obstructive pulmonary disease, multiple organ dysfunction, severe diabetes, heart failure, or chronic kidney disease;
- •Pre-existing neurological disability due to previous brain disease or neurosurgery, defined as a premorbid modified Rankin Scale (mRS) score ≥3;
- •Significant structural abnormalities on neuroimaging, such as extensive encephalomalacia or marked mass effect;
- •Subarachnoid haemorrhage caused by non-aneurysmal aetiologies;
- •Moyamoya disease associated aneurysmal rupture;
- •Other underlying diseases expected to substantially affect prognosis;
- •Active request for ICP monitoring by the patient or family;
- •Any other condition considered unsuitable for enrolment by two investigators;
- •Concurrent participation in another clinical trial.
研究组 & 干预措施
aSAH management guided by continuous intraventricular ICP monitoring
In the acute phase of aSAH (following endovascular or microsurgical occlusion of the ruptured aneurysm), an intraventricular ICP catheter is placed for continuous ICP monitoring. Postoperative ICP management is guided by continuous quantitative ICP measurements according to a predefined ICP-targeted treatment protocol. Other guideline-based treatments are provided in the same manner as in the control group.
干预措施: Intraventricular ICP monitoring-guided management (Other)
Guideline-based Standard Care Group
Guideline-based standard aSAH management is provided without continuous intraventricular ICP monitoring or the predefined ICP-targeted treatment protocol. ICP-related management is not guided by continuous quantitative ICP measurements and is instead based on clinical assessment, imaging findings, and treating physician judgment. Clinically indicated CSF diversion and other standard ICP-lowering treatments are permitted.
结局指标
主要结局
Favourable functional outcome at 3 months
时间窗: 3 months after ictus
The proportion of patients with modified Rankin Scale (mRS) scores of 0-2. The mRS is an ordinal scale ranging from 0 to 6, with higher scores indicating greater disability. An mRS score of 0-2 is defined as a favourable functional outcome.
The rate of good neurological functional prognosis
时间窗: 90 days
The proportion of patients with modified Rankin Scale (mRS) scores 0-2. The mRS is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability. A mRS ≤ 2 indicated a good clinical outcome, and a mRS 5-6 indicated a poor clinical outcome.
次要结局
- Favourable functional outcome assessed by mRS(1 month and 6 months after ictus)
- Favourable functional outcome assessed by Glasgow Outcome Scale-Extended (GOS-E)(1 month, 3 months, and 6 months after ictus)
- All-cause mortality(1 month, 3 months, and 6 months after ictus)
- Symptomatic hydrocephalus requiring permanent CSF shunting(3 months after ictus)
- Delayed cerebral ischemia (DCI)(3 months after ictus)
- New-onset seizures(3 months after ictus)
- All-cause mortality(90 days)
- Incidence of hydrocephalus(90 days)
- The rate of good neurological functional prognosis(30 days, 180days)
- The rate of good prognosis by Glasgow Outcome Scale-Extended (GOS-E)(30 days, 90 days, 180days)
- Incidence of Delayed Cerebral Ischemia(90 days)
- Incidence of epilepsy(90 days)
研究者
Wei Zhu
Vice director of neurosurgery department, Huashan Hospital, Fudan University
Huashan Hospital