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NCT Number: NCT05738083

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location status: Recruiting

Location contact

Xingen Zhu, Prof

CONTACT

[email protected]

13803546020

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. modified Rankin Scale (mRS) for evaluating the prognosis

    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.

  2. Delayed cerebral ischemia (DCI)

    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.

Secondary outcomes

  1. Rebleeding

    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.

  2. Intracranial Aneurysm Re-Rupture

    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.

  3. Hydrocephalus

    Time frame: 30 days post-event

    Hydrocephalus is the abnormal accumulation of cerebrospinal fluid in the brain's ventricles, leading to their dilation.

  4. Clearing Rate of Subarachnoid Hemorrhage

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Ping Hu, MD

CONTACT

[email protected]

13207109734

Xingen Zhu, Prof

CONTACT

[email protected]

13803546020

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Nanchang University

Other

Collaborators

  • Panzhihua Central Hospital
  • Renmin Hospital of Wuhan University
  • Southwest Hospital, China
  • Zhujiang Hospital

Registry information

Official study title

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

Acronym: PROSAH-MPC

Important dates

Study start
2018
Primary completion
2028
Study completion
2029
First posted
Feb 21, 2023
Registry last updated
Apr 30, 2026

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.

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