Intravenous Immunoglobulin for Acute Intracranial Hemorrhage

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Study of Safety and Efficacy of Intravenous Immunoglobulin Therapy in Patients With Acute Intracranial Hemorrhage

Conditions
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Intracranial Hemorrhage, Hypertensive

Intervention / Treatment
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* Drug: Immunoglobulin Therapy
* Other: Standard management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The first-ever primary supratentorial intracerebral basal ganglia hemorrhage 5-30ml. 18-80 years old. No longer than 72 hours from the acute ICH to medication. Glasgow Coma Score ≥8. Exclusion Criteria: Occurrences of secondary intracerebral hemorrhage. Significant past history of disability, modified Rankin Scale（mRS）≥1. Currently taking antitumor drugs, immunosuppressive drugs, or immunomodulatory therapy. Patients with pregnancy, Severe infection, severe heart dysfunction or renal and hepatic injuries. Patients with contraindications for immunoglobulin.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IVIg group<br>Participants will receive immunoglobulin therapy plus standard management. The first intravenous infusion of immunoglobulin must be given within 72 hours after the onset. | Drug: Immunoglobulin Therapy<br>* Immunoglobulin is given intravenously 0.4 g/kg per day for five consecutive days.<br>* Other names: Human Immunoglobulin (pH4) for Intravenous Injection;Other: Standard management<br>* 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.<br>* Other names: Conventional treatment;|
| Other: Control group<br>Participants will receive standard management according to Chinese guidelines for intracerebral Hemorrhage. | Other: Standard management<br>* 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.<br>* Other names: Conventional treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of the patients with mRS of 3 or more |  | 90 days after the onset of ICH | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in hematoma volume |  | At baseline, 7 days, 14 days and 30 days after the onset | 
| 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 | 
| mBI score |  | 30 days, 90 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intravenous immunoglobulin, intracerebral hemorrhage, perihematomal edema