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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 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.

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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.

Conditions Studied

End Stage Liver DIsease Liver Failure

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

FieldValue
Enrollment Target 219 participants
Start Date 2021-12-16
Est. Completion 2024-06-10
Phase NA

Sponsor

Bridge to Life

1 total trials

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What the Registry Record Tells You About NCT05045794

The ClinicalTrials.gov registry entry for NCT05045794 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 219 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 478-participant average among 16 other End Stage Liver DIsease trials with a reported enrollment target (54% lower). The listed sponsor is Bridge to Life, which has 1 total studies on file at ClinicalTrials.gov.

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 reports 16 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.