Intracranial Hemorrhage, HypertensivePhase 2NCT02782897
Intravenous Immunoglobulin for Acute Intracranial Hemorrhage
A Phase 2 study testing Immunoglobulin Therapy and Standard management in people with Intracranial Hemorrhage, Hypertensive, run by Wei Wang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Hemorrhage, Hypertensive
- What is being tested?
- Immunoglobulin Therapy and Standard management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Apr 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Neurology, Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Shabei Xu, Doctor, 86-13554178768, xushabei@126.com
Xiang Luo, Doctor, 86-15172507950, flydottjh@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Intracranial Hemorrhage, Hypertensive
- Being tested
- Immunoglobulin Therapy, Standard management
- Keywords
- intravenous immunoglobulin, intracerebral hemorrhage, perihematomal edema
- Medical subject headings
- Intracranial Hemorrhage, Hypertensive, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunoglobulin TherapyDrug
Also called Human Immunoglobulin (pH4) for Intravenous Injection
Immunoglobulin is given intravenously 0.4 g/kg per day for five consecutive days.
Standard managementOther
Also called Conventional treatment
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Immunoglobulin Therapy; Other: Standard management |
| Control group | Other | Participants will receive standard management according to Chinese guidelines for intracerebral Hemorrhage. Receives: Other: Standard management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of the patients with mRS of 3 or more
Measured: 90 days after the onset of ICH
Secondary outcomes (7)
Changes in hematoma volume
Measured: At baseline, 7 days, 14 days and 30 days after the onset
Change in peripheral edema volume
Measured: At baseline, 7 days, 14 days and 30 days after the onset
All-cause mortality
Measured: 90 days after the onset
mRS score
Measured: 30 days, 90 days after the onset
mBI score
Measured: 30 days, 90 days after the onset
Incidence of severe adverse events
Measured: 30 days, 90 days after the onset
Change in the levels of blood CRP, MMP-9, IL-6, TNF-alpha, and C3
Measured: At baseline, 5 days after the first administration of immunoglobulin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2017 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Hemorrhage, HypertensiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei Wang, Huazhong University of Science and Technology
- Investigators
- Wei Wang, Doctor, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782897
- Sponsor's protocol ID
- 2016ncx01
- Status last verified
- May 2016
- First submitted
- 23 May 2016
- Last updated
- 25 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Safety and Efficacy of Intravenous Immunoglobulin Therapy in Patients With Acute Intracranial Hemorrhage
- ClinicalTrials.gov ID
- NCT02782897
- Acronym / sponsor ID
- 2016ncx01
- Conditions
- Intracranial Hemorrhage, Hypertensive
- Keywords
- intravenous immunoglobulin, intracerebral hemorrhage, perihematomal edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wei WangUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 25 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVIg group | Experimental | Drug: Immunoglobulin Therapy, Other: Standard managementParticipants will receive immunoglobulin therapy plus standard management. The first intravenous infusion of immunoglobulin must be given within 72 hours after the onset. |
| Control group | Other | Other: Standard managementParticipants will receive standard management according to Chinese guidelines for intracerebral Hemorrhage. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunoglobulin TherapyAlso: Human Immunoglobulin (pH4) for Intravenous InjectionImmunoglobulin is given intravenously 0.4 g/kg per day for five consecutive days. | Drug | IVIg group |
| Standard managementAlso: Conventional treatmentStandard 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 | Control group, IVIg group |
Primary outcome
Proportion of the patients with mRS of 3 or more
Time frame: 90 days after the onset of ICH
7 secondary outcomes
Changes in hematoma volume
Time frame: 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
All-cause mortality
Time frame: 90 days after the onset
mRS score
Time frame: 30 days, 90 days after the onset
mBI score
Time frame: 30 days, 90 days after the onset
Incidence of severe adverse events
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Wang, Doctor principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Immunoglobulin Therapy and Standard management in people with Intracranial Hemorrhage, Hypertensive, run by Wei Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shabei Xu, Doctor (86-13554178768, xushabei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of the patients with mRS of 3 or more (time frame: 90 days after the onset of ICH). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2016.