Overview
Deproteinised Calf Blood Serum Injection for the Treatment of Acute Intracerebral Hemorrhage
Status:
Unknown status
Unknown status
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to investigate the efficacy and safety of Deproteinised Calf Blood Serum Injection in alleviating perihematomal edema (PHE) and secondary brain injury, as well as neurologic deficits in patients with acute intracerebral hemorrhage (ICH).Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Beijing Tiantan HospitalCollaborator:
Beijing Stroke Association
Criteria
Inclusion Criteria:1. Diagnosis of spontaneous intracerebral hemorrhage(sICH)
2. Bleeding into deep gray matter (basal ganglionic and thalamus), and the amount of
bleeding between 5 and 30 ml;
3. Age between 18 and 80 years;
4. Presentation within 48 hours of symptom onset, and NCCT at 24 hours need to be done in
patients presenting within 24 hours of symptom onset in order to exclude hematoma
expansion.
5. Informed consent by patients or relatives.
Exclusion Criteria:
1. Â secondary ICH (secondary to trauma, tumor, vascular malformations, ischemic stroke
hemorrhagic transformation, etc.);
2. Glasgow Coma Score of 3-8 at admission;
3. Parenchymal hemorrhage with ventricle involved;
4. Patients with hematoma expansion; .
5. Planned surgery within 3 days of symptom onset;
6. Incompletely absorbed brain hematoma previously;
7. Prestroke modified Rankin score(mRS)>1;
8. Patients with hemorrhagic disease or coagulation disorders;
9. Patients with severe liver and renal insufficiency;.
10. Patients with severe heart failure or other serious systemic diseases;
11. Patients with malignant tumors or ongoing anti-tumor therapy;
12. Patients with a history of dementia or mental disorders;
13. Pregnant or lactating women or those who has a recent fertility plan;
14. Any contraindications to MRI(such as cardiac pacemakers and other metal implants,
claustrophobia);
15. Any other neuroprotective has been applied before randomization;
16. Terminal patients whose life expectancy <90 days;
17. Patients participating in other clinical trials 30 days prior to randomization.