Intravenous Immunoglobulin for Acute Intracranial Hemorrhage
NCT ID: NCT02782897
Last Updated: 2016-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2016-06-30
2018-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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IVIg group
Participants will receive immunoglobulin therapy plus standard management. The first intravenous infusion of immunoglobulin must be given within 72 hours after the onset.
Immunoglobulin Therapy
Immunoglobulin is given intravenously 0.4 g/kg per day for five consecutive days.
Standard 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.
Control group
Participants will receive standard management according to Chinese guidelines for intracerebral Hemorrhage.
Standard 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.
Interventions
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Immunoglobulin Therapy
Immunoglobulin is given intravenously 0.4 g/kg per day for five consecutive days.
Standard 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 18-80 years old.
3. No longer than 72 hours from the acute ICH to medication.
4. Glasgow Coma Score ≥8.
Exclusion Criteria
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.
18 Years
80 Years
ALL
No
Sponsors
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Wei Wang
OTHER
Responsible Party
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Wei Wang
Tongji Hospital, Huazhong University of Science and Technology
Principal Investigators
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Wei Wang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Tongji Hospital
Locations
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Department of Neurology, Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2016ncx01
Identifier Type: -
Identifier Source: org_study_id
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