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Intravenous Immunoglobulin for Acute Intracranial Hemorrhage

Primary Purpose

Intracranial Hemorrhage, Hypertensive

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Immunoglobulin Therapy

Standard management

About this trial

This is an interventional treatment trial for Intracranial Hemorrhage, Hypertensive focused on measuring intravenous immunoglobulin, intracerebral hemorrhage, perihematomal edema

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The first-ever primary supratentorial intracerebral basal ganglia hemorrhage 5-30ml.
18-80 years old.
No longer than 72 hours from the acute ICH to medication.
Glasgow Coma Score ≥8.

Exclusion Criteria:

Occurrences of secondary intracerebral hemorrhage.
Significant past history of disability, modified Rankin Scale（mRS）≥1.
Currently taking antitumor drugs, immunosuppressive drugs, or immunomodulatory therapy.
Patients with pregnancy, Severe infection, severe heart dysfunction or renal and hepatic injuries.
Patients with contraindications for immunoglobulin.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

IVIg group

Control group

Arm Description

Participants will receive immunoglobulin therapy plus standard management. The first intravenous infusion of immunoglobulin must be given within 72 hours after the onset.

Participants will receive standard management according to Chinese guidelines for intracerebral Hemorrhage.

Outcomes

Primary Outcome Measures

Proportion of the patients with mRS of 3 or more

Secondary Outcome Measures

Changes in hematoma volume

Change in peripheral edema volume

All-cause mortality

mRS score

mBI score

Incidence of severe adverse events

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

Full Information

NCT ID

NCT02782897

First Posted

May 23, 2016

Last Updated

May 24, 2016

Sponsor

Wei Wang

1. Study Identification

Unique Protocol Identification Number

NCT02782897

Brief Title

Intravenous Immunoglobulin for Acute Intracranial Hemorrhage

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Unknown status

Study Start Date

June 2016 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Wei Wang

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intracranial Hemorrhage, Hypertensive

Keywords

intravenous immunoglobulin, intracerebral hemorrhage, perihematomal edema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IVIg group

Arm Type

Experimental

Arm Description

Participants will receive immunoglobulin therapy plus standard management. The first intravenous infusion of immunoglobulin must be given within 72 hours after the onset.

Arm Title

Control group

Arm Type

Other

Arm Description

Participants will receive standard management according to Chinese guidelines for intracerebral Hemorrhage.

Intervention Type

Drug

Intervention Name(s)

Immunoglobulin Therapy

Other Intervention Name(s)

Human Immunoglobulin (pH4) for Intravenous Injection

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Standard management

Other Intervention Name(s)

Conventional treatment

Intervention Description

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.

Primary Outcome Measure Information:

Title

Proportion of the patients with mRS of 3 or more

Time Frame

90 days after the onset of ICH

Secondary Outcome Measure Information:

Title

Changes in hematoma volume

Time Frame

At baseline, 7 days, 14 days and 30 days after the onset

Title

Change in peripheral edema volume

Time Frame

At baseline, 7 days, 14 days and 30 days after the onset

Title

All-cause mortality

Time Frame

90 days after the onset

Title

mRS score

Time Frame

30 days, 90 days after the onset

Title

mBI score

Time Frame

30 days, 90 days after the onset

Title

Incidence of severe adverse events

Time Frame

30 days, 90 days after the onset

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The first-ever primary supratentorial intracerebral basal ganglia hemorrhage 5-30ml. 18-80 years old. No longer than 72 hours from the acute ICH to medication. Glasgow Coma Score ≥8. Exclusion Criteria: Occurrences of secondary intracerebral hemorrhage. Significant past history of disability, modified Rankin Scale（mRS）≥1. Currently taking antitumor drugs, immunosuppressive drugs, or immunomodulatory therapy. Patients with pregnancy, Severe infection, severe heart dysfunction or renal and hepatic injuries. Patients with contraindications for immunoglobulin.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shabei Xu, Doctor

Phone

86-13554178768

xushabei@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Xiang Luo, Doctor

Phone

86-15172507950

flydottjh@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei Wang, Doctor

Organizational Affiliation

Tongji Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430030

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shabei Xu, Doctor

Phone

86-13554178768

xushabei@126.com

First Name & Middle Initial & Last Name & Degree

Xiang Luo, Doctor

Phone

86-15172507950

flydottjh@163.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Intravenous Immunoglobulin for Acute Intracranial Hemorrhage

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