Lung Transplant FailureLUTX_phenotypeNCT06125535
Biomolecular Phenotyping of Lung Transplant Recipients
An observational study of Lung Transplant Failure, run by Policlinico Hospital at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant Failure
- What is being tested?
- Sub-phenotyping by biomarkers concentration
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2022to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the consecutive adult patients have undergone primary double LUTX at the promoting institution.
Who may be able to join
- undergone double LUTX
- age > 18 years old
Who cannot join
- single LUTX
- re-transplantation
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico
Milan, Milan, 20122
About this study
Official title: Biomolecular Phenotyping of Lung Transplant Recipients: a Prospective Observational Study
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.
Read the detailed description
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).
- Conditions
- Lung Transplant Failure
- Being tested
- Sub-phenotyping by biomarkers concentration
- Keywords
- lung transplant, primary graft dysfunction, prospective observational study, biomarkers
- Medical subject headings
- Primary Graft Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sub-phenotyping by biomarkers concentrationDiagnostic 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)
| Study group | Role | What they receive |
|---|---|---|
| Hypoinflammatory | By means of latent class analysis, a sub-phenotype of LUTX recipients with down-regulated inflammatory biomarkers Receives: 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 Receives: Diagnostic Test: Sub-phenotyping by biomarkers concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: <= 72 hours from graft reperfusion
Secondary outcomes (1)
28-days organ support free-days
Number of days at 28 days from ICU admission free from: - extracorporeal membrane oxygenation; - mechanical ventilation; - renal replacement therapy; - vasoactive support.
Measured: 28 days from ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start1 Feb 2022
- Primary completion1 Mar 2024
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan
- Responsible party
- Principal investigator, Giacomo Grasselli, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Investigators
- Giacomo Grasselli, Porf, Study director, Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoVittorio Scaravilli, MD, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125535
- Sponsor's protocol ID
- LUTX_phenotype
- Acronym
- LUTX_phenotype
- Status last verified
- Jun 2025
- First submitted
- 4 Nov 2023
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual anonymized data will be available from the promoting center after a reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomolecular Phenotyping of Lung Transplant Recipients: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06125535
- Acronym / sponsor ID
- LUTX_phenotype / LUTX_phenotype
- Conditions
- Lung Transplant Failure
- Keywords
- lung transplant, primary graft dysfunction, prospective observational study, biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Collaborators
- University of Milan
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypoinflammatory | – | Diagnostic Test: Sub-phenotyping by biomarkers concentrationBy means of latent class analysis, a sub-phenotype of LUTX recipients with down-regulated inflammatory biomarkers |
| Hyperinflammatory | – | Diagnostic Test: Sub-phenotyping by biomarkers concentrationBy means of latent class analysis, a sub-phenotype of LUTX recipients with up-regulated inflammatory biomarkers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the consecutive adult patients have undergone primary double LUTX at the promoting institution.
Key inclusion criteria (2 listed)
- undergone double LUTX
- age > 18 years old
Key exclusion criteria (2 listed)
- single LUTX
- re-transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sub-phenotyping by biomarkers concentrationPlasma 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) | Diagnostic test | Hyperinflammatory, Hypoinflammatory |
Primary outcome
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.
1 secondary outcome
28-days organ support free-days
Time frame: 28 days from ICU admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: Yes. Individual anonymized data will be available from the promoting center after a reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giacomo Grasselli, Porf study director
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Vittorio Scaravilli, MD principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplant Failure, run by Policlinico Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Graft Dysfunction (time frame: <= 72 hours from graft reperfusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.