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

NCT ID: NCT03260153

Last Updated: 2017-08-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Deproteinised Calf Blood Serum Injection

Intervention Type: DRUG

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.

Group Type: PLACEBO_COMPARATOR

Placebo (Sodium Chloride)

Intervention Type: DRUG

Interventions

Deproteinised Calf Blood Serum Injection

Intervention Type: DRUG

Placebo (Sodium Chloride)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Stroke Association

UNKNOWN

Sponsor Role: collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xingquan Zhao

Professor of Neurology and Stroke Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xingquan Zhao, MD

Role: CONTACT

zxq@vip.163.com

8610-67098891

Facility Contacts

Xingquan Zhao, MD

Role: primary

zxq@vip.163.com

8610-67098891

Other Identifiers

CBS-ICH

Identifier Type: -

Identifier Source: org_study_id