Intraoperative Assessment of Microcirculatory Function Using Vascular Occlusion Test During Liver… (NCT07658794) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Intraoperative Assessment of Microcirculatory Function Using Vascular Occlusion Test During Liver Transplantation
Greece50 participantsStarted 2026-06
Plain-language summary
Early allograft dysfunction (EAD) remains one of the most important complications following orthotopic liver transplantation (OLT). Currently, there is no established intraoperative biomarker that reliably predicts graft dysfunction at an early stage. Near-infrared spectroscopy (NIRS) combined with the vascular occlusion test (VOT) is a non-invasive method for assessing tissue oxygenation and microcirculatory reserve. This prospective observational study aims to investigate whether VOT-derived parameters, including desaturation slope, recovery slope and post-ischemic hyperemic area under the curve (AUC-H), can predict EAD in liver transplant recipients. Measurements will be performed at four predefined intraoperative timepoints: after induction of anesthesia, during the anhepatic phase, during the neohepatic phase and at the end of surgery. The primary outcome is the occurrence of EAD according to Olthoff criteria.
Who can participate
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:
* Adult patients aged 18 years or older
* Patients scheduled to undergo orthotopic liver transplantation
* Ability to obtain intraoperative Near-Infrared Spectroscopy measurements
* Written informed consent obtained before enrollment
Exclusion Criteria:
* Age younger than 18 years
* Refusal or inability to provide informed consent
* Emergency liver transplantation without sufficient time for enrollment
* Inability to perform the Vascular Occlusion Test or obtain reliable NIRS measurements
* Severe peripheral vascular disease or local upper-limb conditions interfering with monitoring
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
Incidence of Early Allograft Dysfunction Within 7 Days After Liver Transplantation
Timeframe: Within 7 days after liver transplantation
2
Early Allograft Dysfunction
Timeframe: Within 7 days after liver transplantation
Trial details
NCT IDNCT07658794
SponsorIppokrateio General Hospital of Thessaloniki