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Intravenous Immunoglobulin for Acute Intracranial Hemorrhage

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ClinicalTrials.gov Identifier: NCT02782897
Recruitment Status : Unknown
Verified May 2016 by Wei Wang, Huazhong University of Science and Technology.
Recruitment status was:  Not yet recruiting
First Posted : May 25, 2016
Last Update Posted : May 25, 2016
Sponsor:
Information provided by (Responsible Party):
Wei Wang, Huazhong University of Science and Technology

Study Description
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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.

Condition or disease Intervention/treatment Phase
Intracranial Hemorrhage, Hypertensive Drug: Immunoglobulin Therapy Other: Standard management Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study of Safety and Efficacy of Intravenous Immunoglobulin Therapy in Patients With Acute Intracranial Hemorrhage
Study Start Date : June 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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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 Name: 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 Name: Conventional treatment
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 Name: Conventional treatment


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

Secondary Outcome Measures :
  1. Changes in hematoma volume [ Time Frame: At baseline, 7 days, 14 days and 30 days after the onset ]
  2. Change in peripheral edema volume [ Time Frame: At baseline, 7 days, 14 days and 30 days after the onset ]
  3. All-cause mortality [ Time Frame: 90 days after the onset ]
  4. mRS score [ Time Frame: 30 days, 90 days after the onset ]
  5. mBI score [ Time Frame: 30 days, 90 days after the onset ]
  6. Incidence of severe adverse events [ Time Frame: 30 days, 90 days after the onset ]
  7. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02782897


Contacts
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Contact: Shabei Xu, Doctor 86-13554178768 xushabei@126.com
Contact: Xiang Luo, Doctor 86-15172507950 flydottjh@163.com

Locations
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China, Hubei
Department of Neurology, Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Contact: Shabei Xu, Doctor    86-13554178768    xushabei@126.com   
Contact: Xiang Luo, Doctor    86-15172507950    flydottjh@163.com   
Sponsors and Collaborators
Wei Wang
Investigators
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Principal Investigator: Wei Wang, Doctor Tongji Hospital
More Information
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Responsible Party: Wei Wang, Tongji Hospital, Huazhong University of Science and Technology, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT02782897    
Other Study ID Numbers: 2016ncx01
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: May 25, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Wei Wang, Huazhong University of Science and Technology:
intravenous immunoglobulin
intracerebral hemorrhage
perihematomal edema
Additional relevant MeSH terms:
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Intracranial Hemorrhages
Intracranial Hemorrhage, Hypertensive
Hemorrhage
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
Immunologic Factors
Physiological Effects of Drugs