NCT03260153

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

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

• Intracerebral Hemorrhage

Interventions

Type	Name	Description
DRUG	Deproteinised Calf Blood Serum Injection
DRUG	Placebo (Sodium Chloride)

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-12-01
• First posted: 2017-08-24
• Last updated: 2017-08-29

Locations

1 site across 1 country: China