HOPE With Cytokine Filtration in Liver Transplantation (Cyto-HOPE)
Keywords
Abstract
Description
This is a monocentric, pilot, randomized controlled study. Each eligible transplant candidate will be enrolled once an eligible graft has been allocated to him/her. Each enrolled patient will be randomized to either the experimental arm (HOPE-CytoSorb) or the control arm (HOPE-standard).
End-ischemic HOPE will be performed at our center after standard procurement of the graft at the donor hospital, static cold storage preservation during transport and back-table preparation. Dual HOPE, by portal continuous flow and arterial pulsatile flow, will be pressure controlled: portal pressure will be ≤5 mmHg and mean arterial pressure will be ≤30 mmHg. HOPE will be performed in an open system, so the graft will swim in the perfusate flowing out of the vena cava. The recirculating perfusion solution will have the same composition of University of Wisconsin Machine Perfusion Solution. HOPE will be maintained for 4 hours. CytoSorb will be included in the circuit only in the experimental arm.
Scheduled samples of both the perfusate and patient's blood will be analyzed for the levels of TNF-alfa, IL-6, IL-8 and ET-1. A biopsy of the implanted graft will be taken 2 hours after its reperfusion. The patient will be followed for 1 year after transplantation.
Once 10 patients have been enrolled, an interim analysis will be performed by an independent Clinical Endpoint Committee.
Dates
Last Verified: | 02/29/2020 |
First Submitted: | 12/15/2019 |
Estimated Enrollment Submitted: | 12/15/2019 |
First Posted: | 12/17/2019 |
Last Update Submitted: | 03/03/2020 |
Last Update Posted: | 03/04/2020 |
Actual Study Start Date: | 02/29/2020 |
Estimated Primary Completion Date: | 12/31/2021 |
Estimated Study Completion Date: | 01/30/2022 |
Condition or disease
Intervention/treatment
Procedure: HOPE-CytoSorb
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Experimental: HOPE-CytoSorb Patients transplanted with livers preserved by HOPE with cytokine filtration by CytoSorb, a CE approved medical device for extracorporeal cytokine removal | Procedure: HOPE-CytoSorb Cytokine filtration during HOPE |
No Intervention: HOPE-standard Patients transplanted with livers preserved by HOPE without cytokine filtration |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | Yes |
Criteria | RECIPIENTS - Inclusion criteria: age ≥18 years, signed informed consent form - Exclusion criteria: age <18 years, combined liver-other organ transplantation, pre-transplant treatment with plasmapheresis, refusal to consent to the study GRAFTS ELIGIBILITY CRITERIA TO HOPE: - grafts from extended criteria donors with any combination of the following characteristics: age ≥70 years; macrosteatosis ≥35%; diabetes mellitus; severe vasculopathy; anti-HCV or HBsAg positivity (upon biopsy) - grafts from donors with hemodynamic instability - graft from DCD (occasionally) - grafts with an anticipated long cold ischemia time - PARTIAL GRAFTS ARE EXCLUDED FROM THE STUDY |
Outcome
Primary Outcome Measures
1. Incidence of post-reperfusion syndrome [Intraoperatively, during the first 5 minutes after reperfusion of the liver graft]
Secondary Outcome Measures
1. Entity of ischemia-reperfusion injury [2 hours after reperfusion of the liver graft]
2. Incidence of early allograft dysfunction [Postoperative day 7]