The Influencing Factors and Prediction Model of Poor Prognosis of Spontaneous Intraparenchymal Hemorrhage

Recruiting

• Conditions: Spontaneous Intraparenchymal Cerebral Hemorrhage; Spontaneous Cerebellar Haemorrhage; Spontaneous Intracranial Hemorrhage
• Interventions: Other: No intervention

• Registration Number: NCT03899350
• Lead Sponsor: Tang-Du Hospital

Brief Summary

This study was designed to explore the influencing factors of spontaneous intraparenchymal hemorrhage's prognosis and develop predictive models for poor prognosis by establishing a cohort of spontaneous intraparenchymal hemorrhage (including both of the supratentorial intracerebral hemorrhage and cerebellar hemorrhage), and analyzing the correlation between collected variables and patients' outcomes.

Detailed Description

Spontaneous intracranial hemorrhage is an important type of cerebrovascular disease. The disease has an acute onset, a serious condition, and a high mortality rate. Besides, the survivors always live with severe neurological dysfunction. It is essential to determine the influencing factors of poor prognosis, estimate patient's condition and predict the prognosis timely.

This study consists of two parts. The first part establishes a cohort of spontaneous intraparenchymal hemorrhage (including both of the supratentorial intracerebral hemorrhage and cerebellar hemorrhage), and analyzes the influence of different factors, such as surgical methods, on the prognosis. In the second part, a nested case-control study nested in this cohort will be established to analyse the influence of some other factors. The biological specimens are tested. The collected data were analysed to find out the risk factors of poor prognosis and establish a predictive model.

Recruitment and follow-up of the participants is expected to continue after the initial goal is achieved. As a large sample database of intracranial hemorrhage, this cohort will provide more research data for the future exploration of more clinical problems.

Study Timeline

• Study First Submitted: 2019-01-07
• Study First Submitted QC: 2019-03-31
• Study First Posted: 2019-04-02
• Study Start: 2019-07-15
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-22
• Primary Completion: 2023-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Age 18-80；
2. Diagnosed with spontaneous intraparenchymal hemorrhage (both of the supratentorial intracerebral hemorrhage and cerebellar hemorrhage) by Computed Tomography;
3. Admitted within 24h of ictus；
4. Did not undertake treatment before enrollment;
5. Informed consent to participate in the study.

Exclusion Criteria

1. The hemorrhage caused by tumor, arteriovenous malformation, aneurysm or coagulopathy；
2. Concurrent traumatic brain injury；
3. Multiple intracerebral hemorrhage；
4. Undertake any surgery after onset in other hospital；
5. Refuse the treatment after admission;
6. History of craniocerebral surgery；
7. Known advanced demential or disability before onset；
8. Any concurrent serious illness that would interfere with the safety assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease;
9. Confirmed malignant disease or life expectancy less than 6 months due to comorbid diseases;
10. Concurrent serious infectious disease (HIV, tuberculosis etc.)
11. Concurrent coagulation disorders or having taken anti-platelet or anticoagulant drugs;
12. With indications of terminal brain hernia
13. Pregnant or lactating females；
14. Participation in another simultaneous trial of intracerebral hemorrhage treatment；
15. Patients/relatives refuse to be followed up。

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spontaneous Intracerebellar Hemorrhage	No intervention	Participants with spontaneous intracerebellar hemorrhage.
Spontaneous Supratentorial Intracerebral Haemorrhage	No intervention	Participants with spontaneous supratentorial intracerebral haemorrhage.

Primary Outcome Measures

Name	Time	Method
Mortality	12 month after onset	The mortality rate of patients undertook different treatments at 12 month.
Neurological Outcome Assessed by modified Rankin Scale (mRS) Score	1 month after onset	The neurological function state of patients undertook different treatments at 1 month.
Neurological Outcome Assessed by mRS Score	12 month after onset	The neurological function state of patients undertook different treatments at 12 month.

Trial Locations

Locations (1)

Tandu Hospital, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China