Prediction Models for Complications, Disability, and Death in Patients With Aneurysmal Subarachnoid Hemorrhage

Aneurysmal Subarachnoid Hemorrhage Clinical Trial

Official title:

Machine Learning-based Model for Prediction of Complications, Disability, and Death in Patients With Aneurysmal Subarachnoid Hemorrhage

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05738083
• Other study ID #: IIT-O-2023-011
• Status: Active, not recruiting
• Start date: October 1, 2018
• Est. completion date: October 30, 2024

Study information

• Verified date: May 2024
• Source: Second Affiliated Hospital of Nanchang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study aims to prospectively collect the clinical and radiogical features to investigate the associations between the potential risk factors and secondary complications, adverse long-term functional outcomes, and death in patients with aneurysmal subarachnoid haemorrhage (aSAH).

Description:

Aneurysmal subarachnoid haemorrhage (aSAH) is an acute cerebrovascular disease with high mortality and morbidity.

The early and delayed stages of brain injury after subarachnoid hemorrhage is usually accompanied by complications such as vasospams, delayed cerebral ischemia, rebleeding, hydrocephalus, and other organ damage, which determines a poor functional outcome. It is significantly important to investigate the association between the potential clinical and radiogical features with these complications and functional outcome after aSAH, including a well-known factor as total bleeding volume of subarachnoid hemorrhage.

In this study, the investigators prospectively collected a huge dataset of aSAH to fully investigate these correlation, including the association between radiomics features with these complications to prove the role of early radiogical factors. Then, the investigators will train models based on these potential contributing factors to highly predict these complications, disabilty, and death.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1452
• Est. completion date: October 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subarachnoid hemorrhage was confirmed by CT;

• the CTA and DSA examination confirmed is aneurysm rupture caused by subarachnoid hemorrhage;

• bleeding after 24 hours of adept blood routine, biochemical function, blood coagulation function and craniocerebral CT;

• DCI was observed during 3 to 14 days after surgery;

• aneurysm clip by surgery or endovascular embolization.

Exclusion Criteria:

• Aneurysm rupture bleeding time more than 24 hours;

• by CTA and DSA examination found no intracranial aneurysm;

• Traumatic subarachnoid hemorrhage;

• the image data and check blood information is not complete;

• long-term anticoagulant drugs such as aspirin, wave dimensions;

• admitted to hospital with infectious diseases;

• merging other intracranial vascular malformation.

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Diagnostic Test:
• machine learning models
Area under the curve (ROC), accuracy, precise, sensitivity, specificity indicators to show the prediction performance of machine learning models

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi

Sponsors (4)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Nanchang University	Renmin Hospital of Wuhan University, Southwest Hospital, China, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified Rankin Scale for evaluating the prognosis	A score greater than 3 indicates a poor prognosis, while a score less than 3 indicates a good prognosis	12 months
Primary	Delayed cerebral ischemia	A state of transition in cerebral ischemia	30 days
Secondary	Rebleeding	Intracerebral aneurysm rerupture	30 days
Secondary	Hydrocephalus	Obstruction of cerebrospinal fluid circulation leads to ventricle dilation	30 days
Secondary	Clearing rate of subarachnoid hemorrhage	BrainHemoAI software used to quantify subarachnoid hemorrhage volume from admission CT scans to dischage CT scans.	14 days