Intravenous Immunoglobulin for Acute Intracranial Hemorrhage

Intracranial Hemorrhage, Hypertensive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02782897
• Other study ID #: 2016ncx01
• Status: Not yet recruiting
• Phase: Phase 2
• First received: May 23, 2016
• Last updated: May 24, 2016
• Start date: June 2016
• Est. completion date: April 2018

Study information

• Verified date: May 2016
• Source: Huazhong University of Science and Technology
• Contact: Shabei Xu, Doctor
• Phone: 86-13554178768
• Email: xushabei[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Intracranial Hemorrhage, Hypertensive
• Intracranial Hemorrhages

Intervention

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.

Locations

Country	Name	City	State
China	Department of Neurology, Tongji Hospital, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wei Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of the patients with mRS of 3 or more		90 days after the onset of ICH	Yes
Secondary	Changes in hematoma volume		At baseline, 7 days, 14 days and 30 days after the onset	No
Secondary	Change in peripheral edema volume		At baseline, 7 days, 14 days and 30 days after the onset	No
Secondary	All-cause mortality		90 days after the onset	Yes
Secondary	mRS score		30 days, 90 days after the onset	No
Secondary	mBI score		30 days, 90 days after the onset	No
Secondary	Incidence of severe adverse events		30 days, 90 days after the onset	No
Secondary	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	No