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).
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 investigators will enroll 60 acute supratentorial ICH patients. Patients will be assigned randomly to receive either Deproteinised Calf Blood Serum Injection or placebo treatment, which is blinded to evaluator and patients. All patients in the study will receive standard care treatment and clinical, diagnostic, laboratory, safety, and follow-up evaluations. Blood will be drawn and brain MRI will be done in different time course. Follow-up evaluations, including National Institute of Health stroke scale(NIHSS), Stroke impact scale , Glasgow Coma Scale ,Barthel index score and modified Rankin scale assessments, will be done periodically until 90 days after onset.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Beijing Tian Tan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGChanges of cytotoxic and vasogenic edema on day 3 and day 7-10 (MRI evaluation)
Time frame: day 3, day 7-10
Changes of vasogenic edema on day 14 (CT evaluation)
Time frame: day 14
Changes of the biomarkers(MMP3、MMP9、TNF-α、IL-6、CRP) in the peripheral blood on different time course.
Time frame: at admission, day 3,day 3-7,day 14,day 30, day 90
Clinical outcome evaluated by Glasgow Coma Scale(GCS)scores.
Time frame: at admission, day 14, day 30, day 90
Clinical outcome evaluated by NIH Stroke Scale(NIHSS)scores.
Time frame: at admission, day 14, day 30, day 90
Clinical outcome evaluated by Barthel Index(BI) scores.
Time frame: day 14, day 30, day 90
Clinical outcome evaluated by Modified Rankin Scale(mRS)scores.
Time frame: at admission, day 14, day 30, day 90
Clinical outcome evaluated by Stroke Impact Scale (SIS) scores.
Time frame: day 90
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