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10°C vs 4°C Lung Preservation RCT
NCT05898776 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 317 participants |
| Start Date | 2023-06-09 |
| Est. Completion | 2026-11-22 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05898776
The ClinicalTrials.gov registry entry for NCT05898776 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 317 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Health Network, Toronto, which has 67 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05898776 reports 17 study locations spanning 11 distinct geographic areas — top geographies include Other, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05898776?
This trial is sponsored by University Health Network, Toronto, which has 67 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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