Exploring factors affecting prognosis in spontaneous brain hemorrhage

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

This study is trying to find out what factors affect recovery in people who have had a spontaneous brain bleed, by looking at different treatments and patient information.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Tang-Du Hospital (other)
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT03899350 on ClinicalTrials.gov

What this trial studies

This observational study aims to identify the factors influencing the prognosis of spontaneous intraparenchymal hemorrhage by establishing a cohort of affected patients. It will analyze various variables, including surgical methods, to determine their correlation with patient outcomes. Additionally, a nested case-control study will be conducted to further investigate other influencing factors and develop predictive models for poor prognosis. The study will collect biological specimens and data to enhance understanding and provide a large sample database for future research.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 diagnosed with spontaneous intraparenchymal hemorrhage within 24 hours of onset.

Not a fit: Patients with hemorrhages caused by tumors, arteriovenous malformations, or other specific conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved prediction of outcomes for patients with spontaneous intraparenchymal hemorrhage, potentially guiding treatment decisions.

How similar studies have performed: While similar studies have explored prognosis in intracranial hemorrhage, this specific approach to developing predictive models is relatively novel.

Eligibility criteria

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。

Where this trial is running

Xi'an, Shaanxi

• Tandu Hospital, Fourth Military Medical University — Xi'an, Shaanxi, China (RECRUITING)

Study contacts

• Study coordinator: Wei Guo, M.D, Ph.D

Conditions: Spontaneous Intracranial Hemorrhage, Spontaneous Intraparenchymal Cerebral Hemorrhage, Spontaneous Cerebellar Haemorrhage, Treatment Efficacy, Intraparenchymal Hemorrhage, Surgery, Outcome, Prediction Model