NCT02782897

Intravenous Immunoglobulin for Acute Intracranial Hemorrhage

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Wei Wang · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracranial Hemorrhage, Hypertensive

Interventions

Type	Name	Description
DRUG	Immunoglobulin Therapy	Immunoglobulin is given intravenously 0.4 g/kg per day for five consecutive days.
OTHER	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.

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-12-01
• Completion: 2018-04-01
• First posted: 2016-05-25
• Last updated: 2016-05-25

Locations

1 site across 1 country: China