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
- The rate of good neurological functional prognosis
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 a high mortality and disability rate, approximately 85% of SAH cases are attributed to ruptured intracranial aneurysms (RIAs), which is called 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). This escalated ICP, coupled with the compression from the hematoma, severely impairs brain tissue function, leading to a cascade of irreversible neurological impairments, such as abnormal blood pressure, respiratory arrest, and cardiac arrest. Systematic reviews and meta-analysis found that the incidence rate of elevated ICP (ICP > 20mmHg) in post-aSAH patients was 70.69%, with higher levels (according to the Hunt-Hess scale, WFNS scale, or modified Fisher grade) being more prevalent for increased ICP.
The utilization of Intraventricular ICP monitoring in patients with aSAH offers the advantage of obtaining real-time, accurate data on intracranial pressure, enabling more precise and timely control of cranial pressure. However, there is a dearth of high-level randomized controlled trial evidence supporting the use of ICP in the treatment of aSAH. Given the potential utility of ICP monitoring in aSAH management and its current lack of high-level evidence in evidence-based medicine, we intend to pursue the research.
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 treatment based on Intraventricular ICP monitoring
In the acute phase of aSAH (following endovascular or craniotomy occlusion of the aneurysm), a ventricular ICP monitoring probe is surgically implanted. And the postoperative management of ICP is guided by quantifiable ICP parameters. The remaining treatments are consistent with those in the control group.
干预措施: Intraventricular intracranial pressure monitoring (Device)
aSAH treatment without Intraventricular ICP monitoring
Only aSAH treatment surgery is performed without intraventricular ICP monitoring probe implantation. The treatment is not guided by ICP monitoring, and instead, aSAH treatment is conducted based on clinical signs and CT imaging to assess ICP.
结局指标
主要结局
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
- 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