Intravenous Immunoglobulin for Acute Intracranial Hemorrhage

Phase 2

• Conditions: Intracranial Hemorrhage, Hypertensive
• Interventions: Drug: Immunoglobulin Therapy; Other: Standard management

• Registration Number: NCT02782897
• Lead Sponsor: Wei Wang

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.

Study Timeline

• Status Verified: 2016-05
• Study First Submitted: 2016-05-23
• Study First Submitted QC: 2016-05-24
• Last Update Submitted: 2016-05-24
• Study First Posted: 2016-05-25
• Last Update Posted: 2016-05-25
• Study Start: 2016-06
• Primary Completion: 2017-12
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IVIg group	Immunoglobulin Therapy	Participants will receive immunoglobulin therapy plus standard management. The first intravenous infusion of immunoglobulin must be given within 72 hours after the onset.
IVIg group	Standard management	Participants will receive immunoglobulin therapy plus standard management. The first intravenous infusion of immunoglobulin must be given within 72 hours after the onset.
Control group	Standard management	Participants will receive standard management according to Chinese guidelines for intracerebral Hemorrhage.

Primary Outcome Measures

Name	Time	Method
Proportion of the patients with mRS of 3 or more	90 days after the onset of ICH

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Neurology, Tongji Hospital, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China