Analysis of Clinical Outcomes and Host Immune Response to Vascular Graft and Endograft Infections
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Percentage of peripheral blood myeloid-derived suppressor cells among live PBMCs at baseline
研究概览
简要总结
ACHIEVE is a prospective observational cohort and biobank study of patients with suspected or diagnosed central vascular graft or endograft infection. The study also includes patients undergoing elective central vascular graft or endograft implantation and healthy blood donor controls. Participants undergo longitudinal clinical data collection and biospecimen sampling. The study aims to characterize clinical outcomes, host immune responses, inflammatory biomarkers, pathogen-related factors, and novel microbiological diagnostic methods, including microbial cell-free DNA sequencing, in vascular graft and endograft infections.
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
- 是
入选标准
- •Age 18 years or older.
- •Able and willing to provide informed consent.
- •For the vascular graft or endograft infection group: suspected or diagnosed vascular graft or endograft infection in a central vascular prosthesis as determined by the treating clinicians.
- •For the elective vascular graft or endograft control group: planned central vascular graft or endograft implantation.
- •For the healthy blood donor control group: active blood donor registered at Aarhus University Hospital Blood Bank.
- •For the healthy blood donor control group: no current infection or other active disease.
排除标准
- •For the elective vascular graft or endograft control group: surgery performed as an emergency procedure within 24 hours.
- •For the elective vascular graft or endograft control group: reoperation of a previously implanted vascular graft or endograft.
- •For the elective vascular graft or endograft control group: evidence suggestive of ongoing infection in the area of surgery.
- •Unable to provide informed consent.
结局指标
主要结局
Percentage of peripheral blood myeloid-derived suppressor cells among live PBMCs at baseline
时间窗: At baseline/inclusion
Percentage of live PBMCs identified as myeloid-derived suppressor cells by flow cytometry, compared between participants with vascular graft or endograft infection and elective vascular graft/endograft controls.
Proportion of selected VGEI sampling events with clinically adjudicated mNGS positivity
时间窗: At each paired VGEI sampling event from inclusion through follow-up, up to 10 years
Selected VGEI sampling events with final consensus sample-level mNGS result classified as positive divided by all selected VGEI sampling events within the predefined clinical sampling category.
Proportion of selected VGEI sampling events with clinically relevant paired blood culture positivity
时间窗: At each paired VGEI sampling event from inclusion through follow-up, up to 10 years
Selected VGEI sampling events with clinically relevant positive paired blood culture divided by all selected VGEI sampling events within the predefined clinical sampling category.
次要结局
- Proportion of selected VGEI sampling events with additional clinically relevant mNGS yield(At each paired VGEI sampling event from inclusion through follow-up, up to 10 years)
研究者
Rasmus Alstrup Nielsen
Principal Investigator
Aarhus University Hospital