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| Name | Class |
|---|---|
| Beijing Stroke Association | UNKNOWN |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deproteinised Calf Blood Serum Injection | Experimental | 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. |
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| Sodium Chloride Physiological Solution | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deproteinised Calf Blood Serum Injection | Drug |
| ||
| Placebo (Sodium Chloride) |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingquan Zhao, MD | Contact | 8610-67098891 | zxq@vip.163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tian Tan Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100050 | China |
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Drug |
|
| 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 |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017670 |
| Sodium Compounds |