Biomolecular Phenotyping of Lung Transplant Recipients

NCT06125535 | Completed

• 1 other identifier: LUTX_phenotype
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

lung transplant; primary graft dysfunction; prospective observational study; biomarkers

Outcome Measures

Primary Outcomes (1)

• Primary Graft Dysfunction

  PGD incidence, defined and graded following the most recent ISHLT society guidelines, as hypoxia (i.e., PaO2/FiO2 \< 300 mmHg) with bilateral lung infiltrates.

  <= 72 hours from graft reperfusion

Secondary Outcomes (1)

• 28-days organ support free-days

  28 days from ICU admission

Study Arms (2)

Hypoinflammatory

By means of latent class analysis, a sub-phenotype of LUTX recipients with down-regulated inflammatory biomarkers

Diagnostic Test: Sub-phenotyping by biomarkers concentration

Hyperinflammatory

By means of latent class analysis, a sub-phenotype of LUTX recipients with up-regulated inflammatory biomarkers

Diagnostic Test: Sub-phenotyping by biomarkers concentration

Interventions

Sub-phenotyping by biomarkers concentration DIAGNOSTIC_TEST

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)

Hyperinflammatory; Hypoinflammatory

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the consecutive adult patients have undergone primary double LUTX at the promoting institution.

You may qualify if:

• undergone double LUTX
• age \> 18 years old

You may not qualify if:

• single LUTX
• re-transplantation

Sponsors & Collaborators

• Policlinico Hospital: lead
• University of Milan: collaborator

Study Sites (1)

Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico

Milan, Milan, 20122, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples collected at \<6 hours and 36 hours from graft reperfusion. Fresh-frozes. Biobanked at -80°c

MeSH Terms

Conditions

Primary Graft Dysfunction

Condition Hierarchy (Ancestors)

Reperfusion Injury; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Giacomo Grasselli, Porf

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  STUDY DIRECTOR

• Vittorio Scaravilli, MD

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 9, 2023
• Study Start: February 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: June 1, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Any timeframe
• Access Criteria: Request to the PI

Locations

IT (1)