Screening for HHV8 Infection in Solid Organ Transplantation Donors, Candidates and Recipients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Incidence of HHV8 seropositivity among SOT donors and recipients
研究概览
简要总结
Solid organ transplant candidates will undergo serological screening for HHV8 at time of listing and transplantation.
In the event of a recipient/donor mismatch R-/D+ or in the presence of a seropositive recipient (R+), blood levels of HHV8 DNA will be monitored together with specific IGRA for HHV8.
详细描述
Patients on the waiting list for solid organ transplantation will undergo serological screening for HHV8 (lytic and latent antigens) in the pre-transplant phase, both at time of listing and then at the time of transplantation; if seropositivity is found, further investigations will be performed, i.e. blood levels of HHV8 DNA and specific Elispot for HHV8.
As for donors, serological testing for HHV8 (lytic and latent antigens) will be performed.
AFTER SOLID ORGAN TRANSPLANTATION
- Patients found HHV8 seropositive in the pretransplant phase (R +), being at risk of HHV8 reactivation, will be monitored monthly in terms of viremia (HHV8 DNA) and specific IGRA for HHV8 for the first 6 months after transplantation and subsequently every 3 months up to 12 months post transplant.
- In case of patients who were found HHV8 seronegative at time of transplantation, donor serology will be evaluated. In case of R-/D+ mismatch, SOT recipients will receive the same monitoring of R + patients (blood levels of HHV8 DNA and specific IGRA for HHV8 monthly for the first 6 months and then every 3 months up to 12 months after transplantation).
- With reference to lung transplant patients, in cases of R + or R- / D +, HHV8 DNA will also be searched on the BAL obtained during surveillance bronchoscopies (usually at 3, 6 and 12 months after transplantation).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all donors used for transplantation purposes (kidney, liver, lung), including living donors in case of kidney transplantation
排除标准
- •SOT CANDIDATES RECIPIENTS:
- •Inclusion Criteria:
- •All patients listed for solid organ transplantation (lung, liver and kidney)
- •Exclusion Criteria:
结局指标
主要结局
Incidence of HHV8 seropositivity among SOT donors and recipients
时间窗: 2021-2024
Incidence of HHV8 seropositivity among solid organ transplantations donors, candidates and recipients
Incidence of HHV8 mismatch between SOT donors and recipients
时间窗: 2021-2024
Incidence of HHV8 mismatch between solid organ transplantations donors and recipients
次要结局
- Incidence of HHV8 related disease after solid organ transplantation(2021-2025)