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A multicenter, prospective cohort study of intracranial hematoma puncture and drainage combined with urokinase therapy and standard drug therapy under the guidance of early diffusion tensor imaging in acute spontaneous cerebral hemorrhage

A multicenter, prospective cohort study of intracranial hematoma puncture and drainage combined with urokinase therapy and standard drug therapy under the guidance of early diffusion tensor imaging in acute spontaneous cerebral hemorrhage

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100046090
Enrollment
Unknown
Registered
2021-05-04
Start date
2021-04-27
Completion date
Unknown
Last updated
2021-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

spontaneous intracerebral hemorrhage

Interventions

Minimally invasive puncture combined with urokinase group:Minimally invasive puncture combined with urokinase
Standard drug treatment group:Standard drug treatment

Sponsors

The Second Affiliated Hospital of the Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years; 2. Diagnosis of cerebral hemorrhage by CT scan of the head; 3. Calculate the volume of hemorrhagic swell >= 10ml based on the head CT examination; 4. Within 14 days of onset; 5. GCS score 4-14 points before entering the group; 6. Before the onset of mRS 0-1 points.

Exclusion criteria

Exclusion criteria: 1. Combined with aneurysms, arteriovenous malformations, brain trauma, brain tumors, large-area cerebral infarction, ß amyloidosis, severe coagulation dysfunction; 2. Patients with intraventricular hemorrhage or ICH breaking into the ventricle; 3. Any history of brain parenchymal or other intracranial subarachnoid, subdural or epidural hemorrhage and surgical history within the past 30 days; 4. Patients with coagulation dysfunction such as genetics or acquired hemorrhagic constitution, lack of coagulation factors; 5. Hemoglobin1.4; 7. It is expected that long-term anticoagulation and antiplatelet therapy will be needed; 8. Past history of internal hemorrhage, such as gastrointestinal bleeding, urogenital bleeding, and respiratory tract bleeding that is not completely controlled; 9. Myocardial infarction in the past 30 days; 10. Known to have a high risk of embolism, including patients with implanted mechanical heart valves, a history of left heart thrombosis, mitral valve stenosis with atrial fibrillation, acute pericarditis or subacute bacterial endocarditis. Atrial fibrillation without mitral stenosis is suitable; 11. Severe liver damage, ALT>3 times the upper limit of normal, or AST>3 times the upper limit of normal. Severe renal insufficiency, glomerular filtration rate <30ml/min/1.73m2; 12. Patients suffering from Alzheimer's disease or mental illness cannot complete the follow-up plan as required; 13. Combine any serious diseases that may interfere with the test results after evaluation: including diseases such as respiratory system, circulatory system, digestive system, genitourinary system, endocrine system, immune system and blood system; 14. People who currently abuse or rely on drugs or alcohol are expected to have poor compliance and difficult to complete the follow-up; 15. Allergic to urokinase or surgery-related drugs and devices; 16. Women who are pregnant or breastfeeding, or who plan to become pregnant within one year.

Design outcomes

Primary

MeasureTime frame
mRS score;

Countries

China

Contacts

Public ContactYang Qingwu

The Second Affiliated Hospital of the Army Medical University

yangqwmlys@163.com+86 13657638868

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026