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NCT Number: NCT07570680

Hemorrhage Stroke Decision Making Model Based Deep Learning (BrainHemoAI System)

Although hemorrhagic stroke also has the characteristics of high mortality and disability rates, and constitutes a major public health problem worldwide, there is a relative lack of in-depth research teams for hemorrhagic stroke in China. The current preoperative imaging evaluation of spontaneous cerebral hemorrhage is still limited to the traditional Tada formula, and there are subjective differences in diagnosis among different doctors, making it difficult to achieve homogenization in clinical decision-making. Hemorrhagic stroke is a common and frequently occurring disease in Jiangxi Province. Therefore, establishing a new diagnosis and treatment system focused on hemorrhagic stroke can not only fill the research gap in this field in China, improve the accuracy and homogeneity of hemorrhagic stroke diagnosis and treatment, but also promote related research progress to reduce the mortality and disability rates of this disease and improve the clinical prognosis of patients.

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Key information

Conditions

Age range

8 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Nanchang University

Nanchang, China

Location status: Recruiting

Location contact

Xingen Zhu

CONTACT

[email protected]

13803546020

About this study

Hemorrhagic stroke is a serious cerebrovascular disease, accounting for about 20% of all strokes. It refers to cerebral hemorrhage and subarachnoid hemorrhage caused by intracranial vascular diseases such as intracranial aneurysms, cerebral and spinal vascular malformations and moyamoya disease under the effect of blood flow. It has the characteristics of high incidence rate, high disability rate and high mortality rate, and has caused huge economic burden to patients, families and society.

Hemorrhagic stroke is one of the high-risk diseases in Jiangxi Province, and has become a major public health challenge and a key social issue that urgently needs to be addressed. On the one hand, the diagnosis and treatment of hemorrhagic stroke have a certain degree of complexity, involving multiple disciplines, especially neurology and endocrinology, which have established multiple diagnostic, evaluation, treatment, and rehabilitation systems. Different systems have different focuses, but limited by the level of understanding of the disease, there have been only basic treatment principles for decades, and there has been no breakthrough in specific treatment plans. On the other hand, with the development of the economy and the improvement of living standards, clinical physicians and patients not only focus on the survival rate after hemorrhagic stroke, but also pay more attention to neurological function recovery and long-term quality of life. Due to the limitations of detection technology in the past, it was difficult to accurately describe diseases and truly develop individualized diagnosis and treatment plans, resulting in significant differences in patient prognosis. How to leverage advances in diagnosis and treatment technology to ultimately achieve precision, individualization, and homogenization in the diagnosis and treatment of hemorrhagic stroke is a key focus for the future.

Although hemorrhagic stroke also has the characteristics of high mortality and disability rates, and constitutes a major public health problem worldwide, there is a relative lack of in-depth research teams for hemorrhagic stroke in China. The current preoperative imaging evaluation of spontaneous cerebral hemorrhage is still limited to the traditional Tada formula, and there are subjective differences in diagnosis among different doctors, making it difficult to achieve homogenization in clinical decision-making. Hemorrhagic stroke is a common and frequently occurring disease in Jiangxi Province. Therefore, establishing a new diagnosis and treatment system focused on hemorrhagic stroke can not only fill the research gap in this field in China, improve the accuracy and homogeneity of hemorrhagic stroke diagnosis and treatment, but also promote related research progress to reduce the mortality and disability rates of this disease and improve the clinical prognosis of patients.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age >= 8 years old;
  • Patients diagnosed with spontaneous hemorrhagic stroke based on medical history and auxiliary examinations;
  • Received non-contrast computed tomography (NCCT) in the outpatient or emergency department;
  • Treated in accordance with standard clinical guidelines during hospitalization;
  • Have complete clinical data.

Exclusion criteria

  • Had undergone surgical treatment in another hospital before admission;
  • Was in a state of shock upon admission;
  • Had severe heart, liver, or kidney dysfunction or other life-threatening systemic diseases;
  • Died during hospitalization;
  • Had an expected lifespan of less than six months or was unable to complete the study follow-up for other reasons.

Treatment and study plan

Large language model

Diagnostic Test

Automatical diagnosis, treatment decision-making, and risk prediction after spontaneous intracerebral hemorrhage via a trained deep learning larger language model.

Other names: deep learning based diagnosis and treatment decision-making model

Primary outcomes

  1. Area Under Curve

    Time frame: 90-day and 180-day

    90-day and 180-day mRS score, survival status, functional independence (Barthel index).

Secondary outcomes

  1. Sensitivity ,Specificity,True Positive Rate,False Positive Rate

    Time frame: Baseline (admission), 24 hours postoperatively, 3 days postoperatively, 7 days postoperatively, discharge, 90-day follow-up, 180-day follow-up

    Including hospital stay, ICU stay, hospitalization costs, rebleeding, delayed cerebral ischemia, intracranial infection, and hydrocephalus flow surgery needs

Study contacts

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

Ping Hu, PhD;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

  • First Affiliated Hospital of Gannan Medical University
  • First Affiliated Hospital of Zhejiang University
  • Ganzhou City People's Hospital
  • Jiujiang No.1 People's Hospital
  • Renmin Hospital of Wuhan University
  • The First People's Hospital of Xiushui
  • Zhejiang University

Registry information

Official study title

Construction of an Integrated Intelligent Model for Spontaneous Intracerebral Hemorrhage Based on Deep Learning

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 6, 2026
Registry last updated
May 6, 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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