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

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).

Study Overview

• Status: Unknown
• Conditions: Intracerebral Hemorrhage
• Intervention / Treatment: Drug: Deproteinised Calf Blood Serum Injection; Drug: Placebo (Sodium Chloride)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Tian Tan Hospital, Capital Medical University
      • Contact: Xingquan Zhao, MD; Phone Number: 8610-67098891; Email: zxq@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deproteinised Calf Blood Serum Injection; 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.	Drug: Deproteinised Calf Blood Serum Injection
Placebo Comparator: Sodium Chloride Physiological Solution; 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.	Drug: Placebo (Sodium Chloride)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes of cytotoxic and vasogenic edema on day 3 and day 7-10 (MRI evaluation)	day 3, day 7-10
Changes of vasogenic edema on day 14 (CT evaluation)	day 14
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 Outcome Measures

Outcome Measure	Time Frame
Clinical outcome evaluated by Glasgow Coma Scale(GCS)scores.	at admission, day 14， day 30， day 90
Clinical outcome evaluated by NIH Stroke Scale(NIHSS)scores.	at admission, day 14， day 30， day 90
Clinical outcome evaluated by Barthel Index(BI) scores.	day 14， day 30， day 90
Clinical outcome evaluated by Modified Rankin Scale(mRS)scores.	at admission, day 14， day 30， day 90
Clinical outcome evaluated by Stroke Impact Scale (SIS) scores.	day 90

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: Beijing Stroke Association

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: January 5, 2017
• First Submitted That Met QC Criteria: August 21, 2017
• First Posted (Actual): August 24, 2017

Study Record Updates

• Last Update Posted (Actual): August 29, 2017
• Last Update Submitted That Met QC Criteria: August 28, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Intracerebral Hemorrhage; Perihematomal edema; Deproteinised Calf Blood Serum Injection
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: CBS-ICH