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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aneurysmal Subarachnoid Hemorrhage
• Intervention / Treatment: Diagnostic test: Machine Leaning Models

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 Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Xingen Zhu, Prof; Phone Number: 13803546020; Email: zxg2008vip@163.com
• Study Contact Backup: Name: Ping Hu, MD; Phone Number: 13207109734; Email: hp666edu@163.com

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Recruiting
      • The Second Affiliated Hospital of Nanchang University
      • Contact: Xingen Zhu, Prof; Phone Number: 13803546020; Email: zxg2008vip@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Aneurysmal Subarachnoid Hemorrhage (aSAH)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

aneurysmal subarachnoid hemorrhage; primary subarachnoid hemorrhage caused by intracranial ruputured aneurysm

Diagnostic test: Machine Leaning Models; Area Under the Curve (ROC): Measures the overall performance of the model across all classification thresholds. A higher AUC value indicates better performance. Accuracy: The proportion of correctly predicted outcomes (both positive and negative) out of all predictions made. Precision (Positive Predictive Value, PPV): The proportion of correctly predicted positive outcomes out of all predicted positive outcomes. Sensitivity (True Positive Rate, TPR): The proportion of actual positive outcomes that are correctly identified by the model. Specificity (True Negative Rate, TNR): The proportion of actual negative outcomes that are correctly identified by the model.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
modified Rankin Scale (mRS) for evaluating the prognosis	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.	12 months post-event
Delayed cerebral ischemia (DCI)	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.	30 days post-event

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rebleeding	This outcome measures the occurrence of recurrent intracranial hemorrhage from the same or another aneurysm within the study period.	30 days post-event
Intracranial Aneurysm Re-Rupture	This refers to the re-rupture of the aneurysm that caused the initial aSAH or the rupture of a different aneurysm.	30 days post-event
Hydrocephalus	Hydrocephalus is the abnormal accumulation of cerebrospinal fluid in the brain's ventricles, leading to their dilation.	30 days post-event
Clearing Rate of Subarachnoid Hemorrhage	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).	14 days post-admission CT scan

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Nanchang University
• Collaborators: Southwest Hospital, China; Zhujiang Hospital; Renmin Hospital of Wuhan University; Panzhihua Central Hospital
• Investigators: Study Chair: Xingen Zhu, Prof, Second Affiliated Hospital of Nanchang University; Principal Investigator: Qianxue Chen, Prof, Renmin Hospital of Wuhan University

Publications and helpful links

General Publications

• Du S, Wu Y, Tao J, Shu L, Yan T, Xiao B, Lv S, Ye M, Gong Y, Zhu X, Hu P, Wu M. Development and Validation of Machine Learning Models for Outcome Prediction in Patients with Poor-Grade Aneurysmal Subarachnoid Hemorrhage Following Endovascular Treatment. Ther Clin Risk Manag. 2025 Mar 7;21:293-307. doi: 10.2147/TCRM.S504745. eCollection 2025.
• Shu L, Xiao B, Jiang Y, Tang S, Yan T, Wu Y, Wu M, Lv S, Lai X, Zhu X, Hu P, Ye M. Comparison of LVIS and Enterprise stent-assisted coiling embolization for ruptured intracranial aneurysms: a propensity score-matched cohort study. Neurosurg Rev. 2024 Sep 7;47(1):560. doi: 10.1007/s10143-024-02756-8.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2029

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: February 20, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Intracranial Hemorrhages; Pathological Conditions, Signs and Symptoms; Subarachnoid Hemorrhage
• Other Study ID Numbers: IIT-O-2023-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No