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

NCT05738083 | Recruiting DMC

• 1 other identifier: IIT-O-2023-011
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Aneurysmal Subarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Rebleeding

  30 days post-event

• Intracranial Aneurysm Re-Rupture

  30 days post-event

• Hydrocephalus

  30 days post-event

• Clearing Rate of Subarachnoid Hemorrhage

  14 days post-admission CT scan

Study Arms (1)

aneurysmal subarachnoid hemorrhage

primary subarachnoid hemorrhage caused by intracranial ruputured aneurysm

Diagnostic Test: Machine Leaning Models

Interventions

Machine Leaning Models DIAGNOSTIC_TEST

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.

aneurysmal subarachnoid hemorrhage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Aneurysmal Subarachnoid Hemorrhage (aSAH)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead
• Panzhihua Central Hospital: collaborator
• Zhujiang Hospital: collaborator
• Southwest Hospital, China: collaborator
• Renmin Hospital of Wuhan University: collaborator

Study Sites (1)

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 40071129 DERIVED

• 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.

  PMID: 39242449 DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xingen Zhu, Prof

  Second Affiliated Hospital of Nanchang University

  STUDY CHAIR

• Qianxue Chen, Prof

  Renmin Hospital of Wuhan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingen Zhu, Prof

CONTACT

13803546020; zxg2008vip@163.com

Ping Hu, MD

CONTACT

13207109734; hp666edu@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: February 21, 2023
• Study Start: October 1, 2018
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2029
• Last Updated: April 30, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)