Intracranial Hemorrhage, Hypertensive
Conditions
Keywords
intravenous immunoglobulin, intracerebral hemorrhage, perihematomal edema
Brief summary
This pilot study aims to investigate whether intravenous immunoglobulin is safe and effective in alleviating perihematomal edema and neurologic deficits in patients with intracranial hemorrhage.
Detailed description
The trial consists of two groups: IVIg group and control group. Thirty patients will be recruited into IVIg group. Thirty Patients who are matched for age, gender, National Institutes of Health Stroke Scale scores, hematomal volumes, and locations of hematomas, will be selected into control group. Patients in control group just receive standard management, while those in IVIg group will receive standard management plus intravenous immunoglobulin therapy. The outcome assessor is blinded to the group assignments.
Interventions
Immunoglobulin is given intravenously 0.4 g/kg per day for five consecutive days.
OTHERStandard management
Standard management includes: the use of mild sedation, blood pressure control, management of elevated intracranial pressure, glucose management, temperature management, airway maintenance, and management of medical complications.
Sponsors
Wei Wang
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. The first-ever primary supratentorial intracerebral basal ganglia hemorrhage 5-30ml. 2. 18-80 years old. 3. No longer than 72 hours from the acute ICH to medication. 4. Glasgow Coma Score ≥8.
Exclusion criteria
1. Occurrences of secondary intracerebral hemorrhage. 2. Significant past history of disability, modified Rankin Scale（mRS）≥1. 3. Currently taking antitumor drugs, immunosuppressive drugs, or immunomodulatory therapy. 4. Patients with pregnancy, Severe infection, severe heart dysfunction or renal and hepatic injuries. 5. Patients with contraindications for immunoglobulin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of the patients with mRS of 3 or more | 90 days after the onset of ICH |
Secondary
| Measure | Time frame |
|---|---|
| Change in peripheral edema volume | At baseline, 7 days, 14 days and 30 days after the onset |
| All-cause mortality | 90 days after the onset |
| mRS score | 30 days, 90 days after the onset |
| Changes in hematoma volume | At baseline, 7 days, 14 days and 30 days after the onset |
| Incidence of severe adverse events | 30 days, 90 days after the onset |
| Change in the levels of blood CRP, MMP-9, IL-6, TNF-alpha, and C3 | At baseline, 5 days after the first administration of immunoglobulin |
| mBI score | 30 days, 90 days after the onset |
Countries
China
Contacts
Primary ContactShabei Xu, Doctor
Backup ContactXiang Luo, Doctor
Outcome results
None listed