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NCT Number: NCT06125535

Biomolecular Phenotyping of Lung Transplant Recipients

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.

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Key information

Conditions

Lung Transplant Failure Cardiovascular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Primary Graft Dysfunction Reperfusion Injury Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico

Milan, 20122, Italy

About this study

Primary graft dysfunction (PGD) is the most common complication after lung transplant (LUTX). PGD is an acute form of lung injury with an incidence of 30%, defined upon alteration of oxygenation and radiographic criteria occurring <72 hours after graft reperfusion.

The PGD definition does not consider the heterogeneity of clinical manifestations of ischemia-reperfusion (I/R) injury. First, PGD severity may vary from mild radiographic signs to life-threatening lung injury. Second, duration may differ: most patients manifest transient hypoxia, but a minority have persistent respiratory failure. Finally, PGD is associated with hemodynamic and renal failure, suggesting that it might be considered a heterogeneous syndrome characterized by multisystemic widespread endothelial barrier damage and inflammation activation due to I/R injury rather than an alteration of the sole lung function.

Following the new paradigm of precision medicine, the investigators hypothesize that predictive enrichment may allow for detecting different - and potentially treatable - traits (i.e., hypo vs. hyperinflammatory) of PGD and applying targeted treatments to sub-cohorts. As for other critical illnesses (i.e., acute respiratory distress syndrome - ARDS, sepsis), the investigators envision the possibility of carrying out biological subtyping of LUTX patients to select the patients with the lowest chance of harm for treatment. In the similar -but not equivalent- context of ARDS, it has been proven that treatments (e.g., positive end-expiratory pressure, fluid management, simvastatin) that disappointingly failed to benefit the overall patients' population provided benefit in specific patients' subcohorts. Biological phenotyping of LUTX recipients has never been carried out, and literature is ample but sparse regarding early PGD plasmatic biomarkers.

With this prospective observational study, the investigators aim to assess: 1/ whether LUTX recipients can be clustered based on early plasma concentration of biomarkers of inflammation, coagulation, and endothelial activation, and 2/ whether these clusters could be associated with clinical outcomes (and specifically PGD).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • undergone double LUTX
  • age > 18 years old

Exclusion criteria

  • single LUTX
  • re-transplantation

Treatment and study plan

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)

Primary outcomes

  1. Primary Graft Dysfunction

    Time frame: <= 72 hours from graft reperfusion

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

Secondary outcomes

  1. 28-days organ support free-days

    Time frame: 28 days from ICU admission

    Number of days at 28 days from ICU admission free from: - extracorporeal membrane oxygenation; - mechanical ventilation; - renal replacement therapy; - vasoactive support.

Sponsors and collaborators

Lead sponsor

Policlinico Hospital

Other

Collaborators

  • University of Milan

Registry information

Official study title

Biomolecular Phenotyping of Lung Transplant Recipients: a Prospective Observational Study

Acronym: LUTX_phenotype

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Nov 9, 2023
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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