Intravenous Immunoglobulin for Acute Intracranial Hemorrhage

May 24, 2016 updated by: Wei Wang

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Department of Neurology, Tongji Hospital, Huazhong University of Science and Technology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IVIg group
Participants will receive immunoglobulin therapy plus standard management. The first intravenous infusion of immunoglobulin must be given within 72 hours after the onset.
Drug: Immunoglobulin Therapy
Immunoglobulin is given intravenously 0.4 g/kg per day for five consecutive days.
Other Names:
  • Human Immunoglobulin (pH4) for Intravenous Injection
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.
Other Names:
  • Conventional treatment
OTHER: Control group
Participants will receive standard management according to Chinese guidelines for intracerebral Hemorrhage.
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.
Other Names:
  • Conventional treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of the patients with mRS of 3 or more
Time Frame: 90 days after the onset of ICH
90 days after the onset of ICH

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in hematoma volume
Time Frame: At baseline, 7 days, 14 days and 30 days after the onset
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
At baseline, 7 days, 14 days and 30 days after the onset
All-cause mortality
Time Frame: 90 days after the onset
90 days after the onset
mRS score
Time Frame: 30 days, 90 days after the onset
30 days, 90 days after the onset
mBI score
Time Frame: 30 days, 90 days after the onset
30 days, 90 days after the onset
Incidence of severe adverse events
Time Frame: 30 days, 90 days after the onset
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
At baseline, 5 days after the first administration of immunoglobulin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wei Wang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

April 1, 2018

Study Registration Dates

First Submitted

May 23, 2016

First Submitted That Met QC Criteria

May 24, 2016

First Posted (ESTIMATE)

May 25, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

May 25, 2016

Last Update Submitted That Met QC Criteria

May 24, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016ncx01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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