Multi-Center Registry Cohort Study on Prognostic Factors and Prediction Model Construction in Aneurysmal SAH

Recruiting

• Conditions: Aneurysmal Subarachnoid Hemorrhage
• Interventions: Diagnostic Test: Machine Leaning Models

• Registration Number: NCT05738083
• Lead Sponsor: Second Affiliated Hospital of Nanchang University

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.

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2023-02-20
• Study First Posted: 2023-02-21
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Primary Completion: 2028-12-30
• Study Completion: 2029-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
aneurysmal subarachnoid hemorrhage	Machine Leaning Models	primary subarachnoid hemorrhage caused by intracranial ruputured aneurysm

Primary Outcome Measures

Name	Time	Method
modified Rankin Scale (mRS) for evaluating the prognosis	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)	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.

Secondary Outcome Measures

Name	Time	Method
Hydrocephalus	30 days post-event	Hydrocephalus is the abnormal accumulation of cerebrospinal fluid in the brain's ventricles, leading to their dilation.
Clearing Rate of Subarachnoid Hemorrhage	14 days post-admission CT scan	This outcome measures the reduction in the volume of subarachnoid hemorrhage over time, quantified using BrainHemoAI software by comparing admission CT scans to subsequent scans (e.g., at discharge or follow-up).
Rebleeding	30 days post-event	This outcome measures the occurrence of recurrent intracranial hemorrhage from the same or another aneurysm within the study period.
Intracranial Aneurysm Re-Rupture	30 days post-event	This refers to the re-rupture of the aneurysm that caused the initial aSAH or the rupture of a different aneurysm.

Trial Locations

Locations (1)

The Second Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China