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NCT05045794 · ClinicalTrials.gov registry record · NA
Bridge to HOPE: Hypothermic Oxygenated Perfusion Versus Cold Storage Prior to Liver Transplantation
A NA study of End Stage Liver DIsease and Liver Failure, sponsored by Bridge to Life.
- Completed
- Registry status
- NA
- Development phase
- 219
- Enrollment target
- 16
- Study locations
NCT05045794: Completed NA study of End Stage Liver DIsease and Liver Failure, sponsored by Bridge to Life.
NCT05045794 is a NA study of End Stage Liver DIsease and Liver Failure that has completed, run by Bridge to Life. The registered enrollment target is 219 participants, below the 478-participant average among 16 other End Stage Liver DIsease trials with a reported enrollment target (54% lower). The trial reports 16 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05045794, a NA study of End Stage Liver DIsease and Liver Failure, has completed, sponsored by Bridge to Life.
- COMPLETED
- Registry status
- NA
- Development phase
- 219 participants
- Enrollment target
- 16
- Study locations
Study Summary
This is a prospective, multi-center, controlled, randomized, pivotal study to evaluate the safety and effectiveness of the VitaSmart Liver Machine Perfusion System by comparing clinical outcomes in patients undergoing liver transplantation with ex-vivo liver preservation using static cold storage (SCS) followed by hypothermic oxygenated machine perfusion (HOPE) versus SCS only.
Primary Outcome
Proportion of participants with EAD by 7 days post-transplant (or at hospital discharge if prior to 7 days). Defined by the presence of one or more of the following outcomes: * Serum bilirubin ≥10 mg/dL at day 7 post-transplant * INR ≥1.6 at day 7 post-transplant * ALT or AST \>2000 IU/L within the first 7 days post-transplant
Conditions Studied
Interventions
- DEVICE VitaSmart Liver Machine Perfusion System
- OTHER Static cold storage
Study Locations (16)
California
- Loma Linda University Medical Center - San Bernardino
- University of California San Francisco - San Francisco
- Stanford University Medical Center - Stanford
Florida
- Mayo Clinic - Jacksonville
- Cleveland Clinic - Weston
Indiana
- Indiana University - Indianapolis
Louisiana
- Ochsner Clinic Foundation - New Orleans
Massachusetts
- Lahey Hospital and Medical Center - Burlington
Michigan
- Henry Ford Hospital - Detroit
Missouri
- Washington University St. Louis - St Louis
Nebraska
- Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 219 participants |
| Start Date | 2021-12-16 |
| Est. Completion | 2024-06-10 |
| Phase | NA |
What the finished NCT05045794 record still lists
NCT05045794 is an interventional study that assigns participants to a tested intervention. The registered 219 participants enrollment target is mid-sized for trials with a published cap, below the 478-participant average among 16 other End Stage Liver DIsease trials with a reported enrollment target (54% lower).
The record links to 2 conditions, with End Stage Liver DIsease appearing as the primary indexed condition, and to 2 interventions - of which VitaSmart Liver Machine Perfusion System is the first listed.
NCT05045794 lists 16 locations in 13 states (California, Florida, Indiana).
Frequently Asked Questions
What is clinical trial NCT05045794 about?
NCT05045794 is a clinical study titled "Bridge to HOPE: Hypothermic Oxygenated Perfusion Versus Cold Storage Prior to Liver Transplantation". This is a prospective, multi-center, controlled, randomized, pivotal study to evaluate the safety and effectiveness of the VitaSmart Liver Machine Perfusion System by comparing clinical outcomes in patients undergoing liver transplantation with ex-vivo liver preservation using static cold storage (S...
What is the current status of trial NCT05045794?
This trial is currently completed. It is a NA study. The enrollment target is 219 participants. The study started on 2021-12-16. Estimated completion is 2024-06-10.
What conditions does trial NCT05045794 study?
This clinical trial studies the following conditions: End Stage Liver DIsease, Liver Failure.
What interventions are being tested in trial NCT05045794?
The interventions under investigation include: VitaSmart Liver Machine Perfusion System (DEVICE), Static cold storage (OTHER).
Who is sponsoring clinical trial NCT05045794?
This trial is sponsored by Bridge to Life, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05045794 being conducted?
This trial has 16 study locations across California, Florida, Indiana, Louisiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05045794's enrollment target sits among peer trials
219 5th of 16 higher than 12 of 16 other End Stage Liver DIsease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other End Stage Liver DIsease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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