Clinical trial NCT05738083: Multi-Center Registry Cohort Study on Prognostic Factors and Prediction Model Construction in Aneurysmal SAH
Official title: Multi-Center Registry Cohort Study on Prognostic Factors and Prediction Model Construction in Aneurysmal Subarachnoid Hemorrhage
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aneurysmal Subarachnoid Hemorrhage
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
Collaborators: name: Panzhihua Central Hospital
name: Zhujiang Hospital
name: Southwest Hospital, China
name: Renmin Hospital of Wuhan University
First posted: 2023-02-21
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Aneurysmal Subarachnoid Hemorrhage (aSAH)

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: modified Rankin Scale (mRS) for evaluating the prognosis
timeFrame: 12 months post-event
measure: Delayed cerebral ischemia (DCI)
timeFrame: 30 days post-event
Secondary outcomes:
measure: Rebleeding
timeFrame: 30 days post-event
measure: Intracranial Aneurysm Re-Rupture
timeFrame: 30 days post-event
measure: Hydrocephalus
timeFrame: 30 days post-event
measure: Clearing Rate of Subarachnoid Hemorrhage
timeFrame: 14 days post-admission CT scan
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
Study officials:
affiliation: Second Affiliated Hospital of Nanchang University
name: Xingen Zhu, Prof
role: STUDY_CHAIR
affiliation: Renmin Hospital of Wuhan University
name: Qianxue Chen, Prof
role: PRINCIPAL_INVESTIGATOR
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