Intravenous Immunoglobulin for Acute Intracranial Hemorrhage

Wei Wang60 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Intracranial Hemorrhage, Hypertensive

Interventions

Immunoglobulin TherapyDRUG

Immunoglobulin is given intravenously 0.4 g/kg per day for five consecutive days.

Standard managementOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Neurology, Tongji Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, China

Outcomes

Primary Outcomes

Proportion of the patients with mRS of 3 or more

Time frame: 90 days after the onset of ICH

Secondary Outcomes

Changes in hematoma volume

Time frame: At baseline, 7 days, 14 days and 30 days after the onset

Change in peripheral edema volume

Time frame: At baseline, 7 days, 14 days and 30 days after the onset

All-cause mortality

Time frame: 90 days after the onset

mRS score

Time frame: 30 days, 90 days after the onset

mBI score

Time frame: 30 days, 90 days after the onset

Incidence of severe adverse events

Time frame: 30 days, 90 days after the onset

Change in the levels of blood CRP, MMP-9, IL-6, TNF-alpha, and C3

Time frame: At baseline, 5 days after the first administration of immunoglobulin

Central Contacts

Shabei Xu, Doctor

CONTACT

86-13554178768 xushabei@126.com

Xiang Luo, Doctor

CONTACT

86-15172507950 flydottjh@163.com

Data from ClinicalTrials.gov

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