Multi-Center Registry Cohort Study on Prognostic Factors and Prediction Model Construction in Aneurysmal Subarachnoid Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- modified Rankin Scale (mRS) for evaluating the prognosis
研究概览
简要总结
PROSAH-MPC, a collaborative research project among neurosurgical centers in China, focuses on aneurysmal subarachnoid hemorrhage (aSAH). Its aim is to identify prognostic factors and develop robust prediction models for complications, disability, and mortality in aSAH patients. By leveraging a large, multi-center, prospective cohort design, PROSAH-MPC aims to overcome limitations of past studies and provide a more comprehensive understanding of the disease.
详细描述
PROSAH-MPC (Prognostic Factors and Prediction Models in Aneurysmal Subarachnoid Hemorrhage Multi-Center Prospective Cohort) is an ambitious research endeavor that brings together a consortium of neurosurgical centers across various regions to comprehensively investigate the complexities of aneurysmal subarachnoid hemorrhage (aSAH). This multi-faceted study aims to unlock the prognostic factors that underpin the outcomes of patients afflicted with this severe and often life-threatening cerebrovascular disorder.
The primary objective of PROSAH-MPC is to construct and validate robust prediction models that can accurately forecast the risks of complications, disability, and mortality in aSAH patients. By leveraging the strengths of a large, multi-center, prospective cohort design, the study aims to overcome the limitations of previous single-center, limited sample size, or retrospective studies, enabling a more holistic and generalizable understanding of the disease.
Central to the study is the collection of extensive clinical and radiological data from enrolled patients, including demographics, medical histories, treatment regimens, radiological features, and follow-up outcomes. Radiomic analysis of imaging data, such as CT and MRI scans, will be employed to extract subtle but crucial features that may predict patient outcomes by deep learning. This data-rich approach ensures that the prediction models are built on a solid foundation of evidence-based knowledge.
PROSAH-MPC's ultimate goal is to transform the way we approach aSAH management by providing clinicians with reliable tools to assess individual patient risks and tailor treatment plans accordingly. The validated prediction models have the potential to enhance early recognition of high-risk patients, facilitate timely interventions, and ultimately improve patient outcomes and quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subarachnoid hemorrhage confirmed by computed tomography (CT);
- •Cerebral angiography (CTA) and digital subtraction angiography (DSA) examination confirming intracranial aneurysm rupture as the cause of the subarachnoid hemorrhage;
- •Blood routine, biochemical function, blood coagulation function, and craniocerebral CT performed within 24 hours of symptom onset;
- •Underwent aneurysm clipping by surgery or endovascular embolization within 72 hours after-onset.
排除标准
- •Aneurysm rupture bleeding time exceeding 24 hours before hospital admission;
- •Incomplete image data or blood test information;
- •Long-term use of anticoagulant medications such as aspirin or warfarin;
- •Admitted to hospital with active infectious diseases;
- •long-term anticoagulant drugs such as aspirin, wave dimensions;
- •Presence of other intracranial vascular malformations.
研究组 & 干预措施
aneurysmal subarachnoid hemorrhage
primary subarachnoid hemorrhage caused by intracranial ruputured aneurysm
干预措施: Machine Leaning Models (Diagnostic Test)
结局指标
主要结局
modified Rankin Scale (mRS) for evaluating the prognosis
时间窗: 12 months post-event
A score of 3 or greater on the mRS indicates a poor prognosis, with significant disability or dependence on others for daily activities. A score less than 3 indicates a good prognosis, with the patient being able to live independently with minimal or no disability.
Delayed cerebral ischemia (DCI)
时间窗: 30 days post-event
DCI is a common complication after aSAH and refers to a decline in neurological status or the presence of new infarctions on imaging, typically occurring days to weeks after the initial hemorrhage.
次要结局
- Hydrocephalus(30 days post-event)
- Clearing Rate of Subarachnoid Hemorrhage(14 days post-admission CT scan)
- Rebleeding(30 days post-event)
- Intracranial Aneurysm Re-Rupture(30 days post-event)
