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NCT05898776 · ClinicalTrials.gov registry record · NA

10°C vs 4°C Lung Preservation RCT

A NA study of Lung Transplant and Organ Preservation, sponsored by University Health Network, Toronto.

Active
Registry status
NA
Development phase
317
Enrollment target
17
Study locations

NCT05898776 is a NA study of Lung Transplant and Organ Preservation that is active but no longer recruiting, run by University Health Network, Toronto. The registered enrollment target is 317 participants, below the 1,255-participant average among 15 other Lung Transplant trials with a reported enrollment target (75% lower). The trial reports 17 study locations across 11 states.

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The verdict

NCT05898776, a NA study of Lung Transplant and Organ Preservation, is active but no longer recruiting, sponsored by University Health Network, Toronto.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
317 participants
Enrollment target
17
Study locations

Study Summary

Despite lung transplantation (LTx) being the most effective treatment for end-stage lung disease, its success rate is lower than that of other solid organ transplantations. Primary graft dysfunction (PGD) is the most common post-operative complication and a major factor in early mortality and morbidity, affecting \~25% of lung transplant patients. Induced by ischemia reperfusion, PGD represents a severe and acute lung injury that occurs within the first 72 hours after transplantation, and has a significant impact on short- and long-term outcomes, and a significant increase in treatment costs. Any intervention that reduces the risk of PGD will lead to major improvements in short- and long-term transplant outcomes and health care systems. One of the main strategies to reduce the risk and severity of post-transplant PGD is to improve pre-transplant donor lung preservation methods. In current practice, lung preservation is typically performed by cold flushing the organ with a specialized preservation solution, followed by subsequent hypothermic storage on ice (\~4°C). This method continues to be used and applied across different organ systems due to its simplicity and low cost. Using this method for the preservation of donor lungs, the current maximum accepted preservation times have been limited to approximately 6-8h. While the goal of hypothermic storage is to sustain cellular viability during ischemic time through reduced cellular metabolism, lower organ temperature has also been shown to progressively favor mitochondrial dysfunction. Therefore, the ideal temperature for donor organ preservation remains to be defined and should maintain a balance between avoidance of mitochondrial dysfunction and prevention of cellular exhaustion. In addition to that, safe and longer preservation times can lead to multiple advantages such as moving overnight transplants to daytime, more flexibility to transplant logistics, more time for proper donor to recipient matching etc. Build

Conditions Studied

Lung Transplant Organ Preservation

Interventions

  • DEVICE Lung transplantation after 10°C donor lung preservation
  • DEVICE Lung transplantation after standard ice cooler donor lung preservation

Study Locations (17)

Other

  • Medical University of Vienna - Vienna
  • University Hospitals Leuven - Leuven
  • The Saint Joseph Hospital Foundation (Hôpital Marie Lannelongue) - Paris
  • Hospital Universitario 12 de Octubre - Madrid
  • Hospital Universitario Puerta de Hierro-Majadahonda - Madrid
  • Centre Hospitalier Universitaire Vaudois (CHUV) - Lausanne
  • University Hospital Zurich - Zurich

Arizona

  • Dignity Health (St. Joseph's Hospital and Medical Center) - Phoenix

California

  • University of California San Francisco - San Francisco

Florida

  • University of Miami - Coral Gables

Michigan

  • Corewell Health Research Institute - Grand Rapids

Minnesota

  • Mayo Clinic - Rochester

Tennessee

  • Vanderbilt University Medical Center - Nashville

Texas

  • University of Texas Southwestern Medical Center - Dallas

Trial Details

FieldValue
Enrollment Target 317 participants
Start Date 2023-06-09
Est. Completion 2026-11-22
Phase NA

Sponsor

University Health Network, Toronto

23 total trials

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What the Registry Record Tells You About NCT05898776

The ClinicalTrials.gov registry entry for NCT05898776 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 317 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,255-participant average among 15 other Lung Transplant trials with a reported enrollment target (75% lower). The listed sponsor is University Health Network, Toronto, which has 23 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Lung Transplant appearing as the primary indexed condition, and to 2 interventions - of which Lung transplantation after 10°C donor lung preservation is the first listed.

NCT05898776 reports 17 study locations spanning 11 distinct geographic areas - top geographies include Other, Arizona, California.

Frequently Asked Questions

What is clinical trial NCT05898776 about?

NCT05898776 is a clinical study titled "10°C vs 4°C Lung Preservation RCT". Despite lung transplantation (LTx) being the most effective treatment for end-stage lung disease, its success rate is lower than that of other solid organ transplantations. Primary graft dysfunction (PGD) is the most common post-operative complication and a major factor in early mortality and morbid...

What is the current status of trial NCT05898776?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 317 participants. The study started on 2023-06-09. Estimated completion is 2026-11-22.

What conditions does trial NCT05898776 study?

This clinical trial studies the following conditions: Lung Transplant, Organ Preservation.

What interventions are being tested in trial NCT05898776?

The interventions under investigation include: Lung transplantation after 10°C donor lung preservation (DEVICE), Lung transplantation after standard ice cooler donor lung preservation (DEVICE).

Who is sponsoring clinical trial NCT05898776?

This trial is sponsored by University Health Network, Toronto, which has 23 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05898776 being conducted?

This trial has 17 study locations across Arizona, California, Florida, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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