Biomarkers and Inflammation in Solid Organ Transplantation: Relationship With Short- and Long-Term Outcomes

NCT06774339 | Recruiting

• 2 other identifiers: Bio-TrapRC-2024-2790630
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 3

Brief Summary

This is a prospective, tissue-based, low-risk, non-pharmacological study that will include adult patients undergoing solid organ transplantation (heart, liver, lung, kidney) followed at the following Units of the IRCCS Azienda Ospedaliero-Universitaria di Bologna (IRCCS AOUBO):

• Heart Failure and Transplants (heart-lung)
• Internal Medicine for the Treatment of Severe Organ Failures (liver)
• Nephrology, Dialysis, and Transplantation (kidney).

Conditions

Solid Organ Transplantation

Outcome Measures

Primary Outcomes (4)

• Adverse Events in Heart Transplantation

  We will assess post-heart transplant adverse events based on Primary Non-Function (PNF), Primary Graft Dysfunction (PGD), Acute Rejection, Death from any cause, Chronic Rejection, and Major Infectious Complications.

  7 years

• Adverse Events in Liver Transplantation

  We will assess post-heart transplant adverse events based on Primary Non-Function (PNF), Primary Graft Dysfunction (PGD), Acute Rejection, Death from any cause, Chronic Rejection, Major Infectious Complications and Major Cardiovascular Complications (MACE)

  7 years

• Adverse Events in Lung Transplantation

  We will assess post-heart transplant adverse events based on Primary Non-Function (PNF), Acute Rejection, Death from any cause, Chronic Rejection, Major Infectious Complications and Endoscopic Complications.

  7 years

• Adverse Events in Kidney Transplantation

  We will assess post-heart transplant adverse events based on Primary Non-Function (PNF), Delayed Graft Function (DGF), Acute Rejection, Graft Loss, Death from any cause, Chronic Rejection, and Major Cardiovascular Complications (MACE).

  7 years

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

Consecutive adult patients listed for solid organ transplantation (liver, kidney, heart, lung) at the IRCCS Azienda Ospedaliero-Universitaria di Bologna will be enrolled during the study period.

You may qualify if:

• Adult patients (≥ 18 years old at the time of enrollment) who have undergone at least one of the following: Liver transplant, Kidney transplant, Heart transplant, Lung transplant during the study period.
• Informed consent acquisition.

You may not qualify if:

• none

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (3)

IRCCS - Azienda ospedaliero-universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

IRCCS - Azienda ospedaliero-universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

IRCCS - Azienda ospedaliero-universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The tissue study involves sampling, preservation, and experimental analysis of: * Blood sample * Routine biopsies of the transplanted organ * Perfusion and/or preservation fluid of the transplanted organ * Urine sample * Bronchoalveolar lavage (only for lung transplants)

Study Officials

• Marco G Masetti, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Masetti, MD

CONTACT

0512143725; scompenso.trapiantocuore@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 14, 2025
• Study Start: October 10, 2024
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: January 14, 2025

Record last verified: 2024-12

Locations

IT (3)