Clinical Outcomes and Host Immune Response in Vascular Graft and Endograft Infections (NCT07696884) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Outcomes and Host Immune Response in Vascular Graft and Endograft Infections
Denmark300 participantsStarted 2024-05-17
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of peripheral blood myeloid-derived suppressor cells among live PBMCs at baseline
Timeframe: At baseline/inclusion
2
Proportion of selected VGEI sampling events with clinically adjudicated mNGS positivity
Timeframe: At each paired VGEI sampling event from inclusion through follow-up, up to 10 years
3
Proportion of selected VGEI sampling events with clinically relevant paired blood culture positivity
Timeframe: At each paired VGEI sampling event from inclusion through follow-up, up to 10 years