NCT02782897

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

May 25, 2016

Status Verified

May 1, 2016

Enrollment Period

1.5 years

First QC Date

May 23, 2016

Last Update Submit

May 24, 2016

Conditions

Intracranial Hemorrhage, Hypertensive

Keywords

intravenous immunoglobulinintracerebral hemorrhageperihematomal edema

Outcome Measures

Primary Outcomes (1)

  • Proportion of the patients with mRS of 3 or more

    90 days after the onset of ICH

Secondary Outcomes (7)

  • 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

  • All-cause mortality

    90 days after the onset

  • mRS score

    30 days, 90 days after the onset

  • mBI score

    30 days, 90 days after the onset

  • +2 more secondary outcomes

Study Arms (2)

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 TherapyOther: Standard management

Control group

OTHER

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

Other: Standard management

Interventions

Immunoglobulin TherapyDRUG

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

Also known as: Human Immunoglobulin (pH4) for Intravenous Injection
IVIg group
Standard managementOTHER

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.

Also known as: Conventional treatment
Control groupIVIg group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Intracranial Hemorrhage, HypertensiveCerebral Hemorrhage

Interventions

Immunization, PassiveImmunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative TechniquesImmunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Wei Wang, Doctor

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shabei Xu, Doctor

CONTACT

86-13554178768xushabei@126.com

Xiang Luo, Doctor

CONTACT

86-15172507950flydottjh@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Tongji Hospital, Huazhong University of Science and Technology

Study Record Dates

First Submitted

May 23, 2016

First Posted

May 25, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2017

Study Completion

April 1, 2018

Last Updated

May 25, 2016

Record last verified: 2016-05

Locations

CN(1)