Deproteinised Calf Blood Serum Injection for the Treatment of Acute Intracerebral Hemorrhage

Recruiting

Phase N/A Results N/A

Trial Description

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).

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 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.

Conditions

Interventions

  • Deproteinised Calf Blood Serum Injection Drug
    ARM 1: Kind: Experimental
    Label: Deproteinised Calf Blood Serum Injection
    Description: Participants will be randomly assigned to receive Deproteinised Calf Blood Serum Injection or placebo within 1 hour after randomization, once a day for 14 days.
  • Placebo (Sodium Chloride) Drug
    ARM 1: Kind: Experimental
    Label: Sodium Chloride Physiological Solution
    Description: Participants will be randomly assigned to receive Deproteinised Calf Blood Serum Injection or placebo within 1 hour after randomization, once a day for 14 days.

Outcomes

Type Measure Time Frame Safety Issue
Primary Changes of cytotoxic and vasogenic edema on day 3 and day 7-10 (MRI evaluation) day 3, day 7-10
Primary Changes of vasogenic edema on day 14 (CT evaluation) day 14
Primary Changes of the biomarkers(MMP3、MMP9、TNF-α、IL-6、CRP) in the peripheral blood on different time course. at admission, day 3,day 3-7,day 14,day 30, day 90
Secondary Clinical outcome evaluated by Glasgow Coma Scale(GCS)scores. at admission, day 14, day 30, day 90
Secondary Clinical outcome evaluated by NIH Stroke Scale(NIHSS)scores. at admission, day 14, day 30, day 90
Secondary Clinical outcome evaluated by Barthel Index(BI) scores. day 14, day 30, day 90
Secondary Clinical outcome evaluated by Modified Rankin Scale(mRS)scores. at admission, day 14, day 30, day 90
Secondary Clinical outcome evaluated by Stroke Impact Scale (SIS) scores. day 90

Sponsors