Aneurysmal Subarachnoid HemorrhagePROSAH-MPCNCT05738083
Multi-Center Registry Cohort Study on Prognostic Factors and Prediction Model Construction in Aneurysmal SAH
An observational study of Aneurysmal Subarachnoid Hemorrhage, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage
- What is being tested?
- Machine Leaning Models
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2018to 30 Dec 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Aneurysmal Subarachnoid Hemorrhage (aSAH)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Xingen Zhu, Prof, 13803546020, zxg2008vip@163.com
About this study
Official title: Multi-Center Registry Cohort Study on Prognostic Factors and Prediction Model Construction in Aneurysmal Subarachnoid Hemorrhage
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.
Read the detailed description
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
- Aneurysmal Subarachnoid Hemorrhage
- Being tested
- Machine Leaning Models
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Machine Leaning ModelsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| aneurysmal subarachnoid hemorrhage | primary subarachnoid hemorrhage caused by intracranial ruputured aneurysm Receives: Diagnostic Test: Machine Leaning Models |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 days post-event
Secondary outcomes (4)
Rebleeding
This outcome measures the occurrence of recurrent intracranial hemorrhage from the same or another aneurysm within the study period.
Measured: 30 days post-event
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.
Measured: 30 days post-event
Hydrocephalus
Hydrocephalus is the abnormal accumulation of cerebrospinal fluid in the brain's ventricles, leading to their dilation.
Measured: 30 days post-event
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).
Measured: 14 days post-admission CT scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Oct 2018
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Nanchang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Panzhihua Central Hospital, Zhujiang Hospital, Southwest Hospital, China, Renmin Hospital of Wuhan University
- Responsible party
- Sponsor
- Investigators
- Xingen Zhu, Prof, Study chair, Second Affiliated Hospital of Nanchang UniversityQianxue Chen, Prof, Principal investigator, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738083
- Sponsor's protocol ID
- IIT-O-2023-011
- Acronym
- PROSAH-MPC
- Status last verified
- Dec 2025
- First submitted
- 16 Nov 2022
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40071129Shu 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.
PubMed 39242449Hu P, Wu Y, Yan T, Shu L, Liu F, Xiao B, Ye M, Wu M, Lv S, Zhu X. Deep learning-based quantification of total bleeding volume and its association with complications, disability, and death in patients with aneurysmal subarachnoid hemorrhage. J Neurosurg. 2024 Mar 29;141(2):343-354. doi: 10.3171/2024.1.JNS232280. Print 2024 Aug 1.
PubMed 38552240
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Registry Cohort Study on Prognostic Factors and Prediction Model Construction in Aneurysmal Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT05738083
- Acronym / sponsor ID
- PROSAH-MPC / IIT-O-2023-011
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Collaborators
- Panzhihua Central Hospital, Zhujiang Hospital, Southwest Hospital, China, Renmin Hospital of Wuhan University
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aneurysmal subarachnoid hemorrhage | – | Diagnostic Test: Machine Leaning Modelsprimary subarachnoid hemorrhage caused by intracranial ruputured aneurysm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Aneurysmal Subarachnoid Hemorrhage (aSAH)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Machine Leaning ModelsArea 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. | Diagnostic test | aneurysmal subarachnoid hemorrhage |
Primary outcome
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.
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.
4 secondary outcomes
Rebleeding
Time frame: 30 days post-event
Intracranial Aneurysm Re-Rupture
Time frame: 30 days post-event
Hydrocephalus
Time frame: 30 days post-event
Clearing Rate of Subarachnoid Hemorrhage
Time frame: 14 days post-admission CT scan
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Derived from this study: PubMed 40071129Du 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.
- Derived from this study: PubMed 39242449Shu 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.
- Derived from this study: PubMed 38552240Hu P, Wu Y, Yan T, Shu L, Liu F, Xiao B, Ye M, Wu M, Lv S, Zhu X. Deep learning-based quantification of total bleeding volume and its association with complications, disability, and death in patients with aneurysmal subarachnoid hemorrhage. J Neurosurg. 2024 Mar 29;141(2):343-354. doi: 10.3171/2024.1.JNS232280. Print 2024 Aug 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xingen Zhu, Prof study chair
Second Affiliated Hospital of Nanchang University
Qianxue Chen, Prof principal investigator
Renmin Hospital of Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysmal Subarachnoid Hemorrhage, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xingen Zhu, Prof (13803546020, zxg2008vip@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Scale (mRS) for evaluating the prognosis (time frame: 12 months post-event). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05738083, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.