Treating Donors With Intravenous Immunoglobulin to Reduce Donor-Derived Infections
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Next-Generation Sequencing (NGS) Results of Bacteremia or Viremia in Transplant Recipient
研究概览
简要总结
The goal of this clinical trial is to learn about the benefit of IVIG in donor-derived infections and the potential immunomodulatory effect on transplanted organs. The main questions it aims to answer are:
- How effective IVIG is in preventing donor-derived infections
- Does IVIG has potential immunomodulatory effect on transplanted organs
详细描述
Donor-derived infections are defined as any infection present in the donor that is transmitted to one or more recipient. Donor-derived infections can be categorized into two groups: "expected" and "unexpected" infections. Expected transmissions occur when the donor is known to have an infection, as demonstrated by positive serology or nucleic acid test (NAT) result for cytomegalovirus (CMV), Epstein-Barr virus (EBV) or hepatitis B and C, or positive cultures in the donor at the time of donation. Unexpected transmissions may occur despite current screening strategies and are not expected in the donor at the time of organ placement.
Intravenous immunoglobulins (IVIG) are produced by pooling together of serum immunoglobulins from multiple donors, and are known to have powerful immunomodulatory and anti-inflammatory functions in vitro and in vivo. The goal of this study is to figure out the benefit of IVIG in donor-derived infections and the potential immunomodulatory effect on transplanted organs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any person approved as a transplant donor with recipient who has never undergone a previous transplantation
- •Transplant donor must be 6 years old or older
- •They must have provided signed informed consent
- •The donors must be willing to contribute samples of blood
排除标准
- •Any potential transplant donor who is receiving or have received anti-herpes medication in the past week
- •Any potential transplant donor to a recipient who has received a previous solid organ transplant
- •Any potential transplant donor who is immunosuppressed due to medical disease and/or immunosuppressive or immunomodulating medications
- •Any potential transplant donor who is on corticosteroids
研究组 & 干预措施
IVIG
干预措施: IVIG (Drug)
结局指标
主要结局
Next-Generation Sequencing (NGS) Results of Bacteremia or Viremia in Transplant Recipient
时间窗: 14 days
NGS is a technology for determining the sequence of DNA or RNA to study genetic variation associated with diseases like bacteremia and viremia.
Incidence of Bacteremia or Viremia in Transplant Recipient
时间窗: 14 days
次要结局
- Incidence of Acute Rejection in Transplant Recipient(1 month)