A Pilot Study of Safety and Efficacy of Intravenous Immunoglobulin Therapy in Patients With Acute Intracranial Hemorrhage
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of the patients with mRS of 3 or more
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Occurrences of secondary intracerebral hemorrhage.
- •Significant past history of disability, modified Rankin Scale（mRS）≥
- •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.
研究组 & 干预措施
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.
干预措施: Immunoglobulin Therapy (Drug)
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.
干预措施: Standard management (Other)
Control group
Participants will receive standard management according to Chinese guidelines for intracerebral Hemorrhage.
干预措施: Standard management (Other)
结局指标
主要结局
Proportion of the patients with mRS of 3 or more
时间窗: 90 days after the onset of ICH
次要结局
- 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)
- Incidence of severe adverse events(30 days, 90 days after the onset)
- Change in the levels of blood CRP, MMP-9, IL-6, TNF-alpha, and C3(At baseline, 5 days after the first administration of immunoglobulin)
研究者
Wei Wang
Tongji Hospital, Huazhong University of Science and Technology
Huazhong University of Science and Technology