Status:
UNKNOWN
Deproteinised Calf Blood Serum Injection for the Treatment of Acute Intracerebral Hemorrhage
Lead Sponsor:
Beijing Tiantan Hospital
Collaborating Sponsors:
Beijing Stroke Association
Conditions:
Intracerebral Hemorrhage
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 neurolog...
Detailed Description
The study hypothesized that administration of Deproteinised Calf Blood Serum Injection would alleviate PHE and secondary brain injury, thus improving clinical outcomes in patients with ICH. The invest...
Eligibility Criteria
Inclusion
- Diagnosis of spontaneous intracerebral hemorrhage(sICH)
- Bleeding into deep gray matter (basal ganglionic and thalamus), and the amount of bleeding between 5 and 30 ml;
- Age between 18 and 80 years;
- 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.
- Informed consent by patients or relatives.
Exclusion
- Â secondary ICH (secondary to trauma, tumor, vascular malformations, ischemic stroke hemorrhagic transformation, etc.);
- Glasgow Coma Score of 3-8 at admission;
- Parenchymal hemorrhage with ventricle involved;
- Patients with hematoma expansion; .
- Planned surgery within 3 days of symptom onset;
- Incompletely absorbed brain hematoma previously;
- Prestroke modified Rankin score(mRS)\>1;
- Patients with hemorrhagic disease or coagulation disorders;
- Patients with severe liver and renal insufficiency;.
- Patients with severe heart failure or other serious systemic diseases;
- Patients with malignant tumors or ongoing anti-tumor therapy;
- Patients with a history of dementia or mental disorders;
- Pregnant or lactating women or those who has a recent fertility plan;
- Any contraindications to MRI(such as cardiac pacemakers and other metal implants, claustrophobia);
- Any other neuroprotective has been applied before randomization;
- Terminal patients whose life expectancy \<90 days;
- Patients participating in other clinical trials 30 days prior to randomization.
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03260153
Start Date
January 1 2017
Last Update
August 29 2017
Active Locations (1)
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1
Beijing Tian Tan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050