Clinical Trial: Intravenous Immunoglobulin for Acute Intracranial Hemorrhage

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Wei Wang

Current Primary Outcome: Proportion of the patients with mRS of 3 or more [ Time Frame: 90 days after the onset of ICH ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Huazhong University of Science and Technology

Dates:
Date Received: May 23, 2016
Date Started: June 2016
Date Completion: April 2018
Last Updated: May 24, 2016
Last Verified: May 2016