Intravenous Immunoglobulin for Acute Intracranial Hemorrhage | NCT02782897

Studies
Intravenous Immunoglobulin for Acute Intracranial Hemorrhage

NCT02782897

Sponsor

Wei Wang

Status

Unknown status

Last Update Posted

May 25, 2016Estimated

Enrollment

60Estimated

Phase

Phase 2

Conditions

Intracranial Hemorrhage, Hypertensive

Interventions

Immunoglobulin Therapy
Standard management

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Dec 2017Estimated

Completion Date

Apr 2018Estimated

First Submitted Date

May 23, 2016

First Submission Date that Met QC Criteria

May 24, 2016

First Posted Date

May 25, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2016

Last Update Posted Date

May 25, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wei Wang, Tongji Hospital, Huazhong University of Science and Technology, Huazhong University of Science and TechnologySponsor-Investigator

Lead Sponsor

Wei WangOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IVIg group	Experimental	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 Other: Standard management
Control group	Other	Participants will receive standard management according to Chinese guidelines for intracerebral Hemorrhage.	Other: Standard management

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Immunoglobulin Therapy	Drug	Immunoglobulin is given intravenously 0.4 g/kg per day for five consecutive days.	IVIg group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Changes in hematoma volume		At baseline, 7 days, 14 days and 30 days after the onset
Change in peripheral edema volume		At baseline, 7 days, 14 days and 30 days after the onset

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shabei Xu, Doctor	Contact	86-13554178768		xushabei@126.com
Xiang Luo, Doctor	Contact	86-15172507950		flydottjh@163.com

Overall Officials

Name	Affiliation	Role
Wei Wang, Doctor	Tongji Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurology, Tongji Hospital, Huazhong University of Science and Technology		Wuhan	Hubei	430030	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020299	Intracranial Hemorrhage, Hypertensive
D002543	Cerebral Hemorrhage

Ancestor Terms

ID	Term
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007116	Immunization, Passive
D016756	Immunoglobulins, Intravenous

Ancestor Terms

ID	Term
D007114	Immunization
D007167	Immunotherapy
D056747	Immunomodulation
D001691	Biological Therapy

Browse Leaves

Not provided

Browse Branches

Not provided