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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital of Nanchang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial population

Patients with Aneurysmal Subarachnoid Hemorrhage (aSAH)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

5,000 Participants
are divided into 1 treatment group
Group A: aneurysmal subarachnoid hemorrhage1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months post-event
2

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.

Time frame
30 days post-event

Secondary outcomes

1

Rebleeding

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
2

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.

Time frame
30 days post-event
3

Hydrocephalus

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

Time frame
30 days post-event
4

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).

Time frame
14 days post-admission CT scan

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital of Nanchang University

Lead sponsor

Panzhihua Central Hospital

Collaborator

Zhujiang Hospital

Collaborator

Southwest Hospital, China

Collaborator

Renmin Hospital of Wuhan University

Collaborator