Intravenous Immunoglobulin for Acute Intracranial Hemorrhage

Wei Wang

Status and phase: Unknown; Phase 2

Conditions: Intracranial Hemorrhage, Hypertensive

Treatments: Drug: Immunoglobulin Therapy; Other: Standard management

Study type: Interventional

Funder types: Other

Identifiers

NCT02782897

2016ncx01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

IVIg group

Experimental group

Description:

Participants will receive immunoglobulin therapy plus standard management. The first intravenous infusion of immunoglobulin must be given within 72 hours after the onset.

Treatment:

Other: Standard management

Drug: Immunoglobulin Therapy

Control group

Other group

Description:

Participants will receive standard management according to Chinese guidelines for intracerebral Hemorrhage.

Treatment:

Other: Standard management