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Biomolecular Phenotyping of Lung Transplant Recipients

NCT06125535 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2025-06-18

No results posted yet for this study

Summary

Primary graft dysfunction (PGD) is a common problem after a lung transplant. It's a sudden lung injury that affects around 30% of patients within 72 hours of getting a new lung. PGD can vary in severity, from mild issues seen on X-rays to severe lung problems, and it can also affect other parts of the body, like the heart and kidneys.

The investigators believe that using precision medicine can identify different groups of patients with varying levels of inflammation and provide them with treatments tailored to their specific conditions. This approach has been successful in treating other serious conditions like acute respiratory distress syndrome (ARDS). Currently, researchers haven't classified lung transplant patients in this way, and there's limited information on early blood markers for PGD.

In an upcoming study, the investigators aim to group lung transplant patients based on their blood markers related to inflammation, blood clotting, and blood vessel problems. The investigators also want to see if these groups are linked to their overall outcomes, especially when it comes to PGD.

Conditions

  • Lung Transplant Failure

Interventions

DIAGNOSTIC_TEST

Sub-phenotyping by biomarkers concentration

Plasma will be collected at ICU admission (i.e., \< 6 hours from graft reperfusion), centrifuged (1500G for 15 min), frozen at -80°c, and then centralized at the Institutional laboratory. The following biomarkers will be assessed: Interleukin-1β, Interleukin-2, Interleukin-6, Interferon-γ, Tumor Necrosis Factor-alpha (TNF-α), chemokine (C-C motif) ligand-2 (CCL-2), Interleukin-15 (IL-15), Ferritin, and D-dimer, by a point-of-care biochip-array device (RANDOX, Multistat)

Sponsors & Collaborators

  • University of Milan

    collaborator OTHER

  • Policlinico Hospital

    lead OTHER

Principal Investigators

  • Giacomo Grasselli, Porf · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  • Vittorio Scaravilli, MD · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2024-03-01
Completion
2025-06-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06125535 on ClinicalTrials.gov