The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Location status: Recruiting
NCT Number: NCT05738083
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Nanchang, Jiangxi, 330006, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: 30 days post-event
This outcome measures the occurrence of recurrent intracranial hemorrhage from the same or another aneurysm within the study period.
Time frame: 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.
Time frame: 30 days post-event
Hydrocephalus is the abnormal accumulation of cerebrospinal fluid in the brain's ventricles, leading to their dilation.
Time frame: 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).
Contact information is provided by the study sponsor or research team.
Ping Hu, MD
CONTACT
Xingen Zhu, Prof
CONTACT
Second Affiliated Hospital of Nanchang University
Other
Multi-Center Registry Cohort Study on Prognostic Factors and Prediction Model Construction in Aneurysmal Subarachnoid Hemorrhage
Acronym: PROSAH-MPC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07614906
Aneurysmal Subarachnoid Hemorrhage, Brain Diseases
Boston, Massachusetts, United States
View Trial DetailsNCT07250958
Aneurysmal Subarachnoid Hemorrhage, Brain Diseases
Louisville, Kentucky, United States
View Trial DetailsNCT06284642
Aneurysmal Subarachnoid Hemorrhage, Brain Diseases
Hefei, Anhui, China
View Trial DetailsNCT06863480
Aneurysmal Subarachnoid Hemorrhage, Brain Diseases
Gainesville, Florida, United States
View Trial Details