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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2029-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Poor Grade Aneurysmal Subarachnoid Hemorrhage Study Group

NCT04945603

Subarachnoid Hemorrhage, Aneurysmal Poor Grade Subarachnoid Hemorrhage

RECRUITING

Trial of Prophylactic Decompressive Craniectomy for Poor-grade Aneurysmal Subarachnoid Hemorrhage

NCT02995928

Subarachnoid Hemorrhage, Aneurysmal

UNKNOWN NA

A Multicenter Registry Study of Aneurysmal SAH

NCT03094975

Subarachnoid Hemorrhage, Aneurysmal Time Delay

UNKNOWN

The Prospective Cohort Study on the Benefit-risk of Antithrombotic or Anticoagulant Therapy in Patients With Unruptured Intracranial Aneurysms Associated With Ischemic Heart Disease or Ischemic Cerebrovascular Disease

NCT03153878

Intracranial Aneurysm Natural History Ischemic Heart Disease +1 more

UNKNOWN

Prospective, Multicenter Cohort Study on the Safety and Efficacy of Treatment for Middle Cerebral Artery Aneurysms

NCT04927520

Middle Cerebral Artery Aneurysm

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aneurysmal Subarachnoid Hemorrhage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

aneurysmal subarachnoid hemorrhage

primary subarachnoid hemorrhage caused by intracranial ruputured aneurysm

Machine Leaning Models

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No