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

Not Applicable

• Conditions: Intracerebral Hemorrhage
• Interventions: Drug: Deproteinised Calf Blood Serum Injection; Drug: Placebo (Sodium Chloride)

• Registration Number: NCT03260153
• Lead Sponsor: Beijing Tiantan Hospital

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.

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-05
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-21
• Study First Posted: 2017-08-24
• Last Update Submitted: 2017-08-28
• Last Update Posted: 2017-08-29
• Primary Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deproteinised Calf Blood Serum Injection	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.
Sodium Chloride Physiological Solution	Placebo (Sodium Chloride)	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.

Primary Outcome Measures

Name	Time	Method
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
Changes of cytotoxic and vasogenic edema on day 3 and day 7-10 (MRI evaluation)	day 3, day 7-10

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Beijing Tian Tan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China