Ex Vivo Lung Perfusion in Bergamo Lung Transplant Program

NCT03053349 | Completed

• 1 other identifier: EVLP Bergamo - nr 2016-0194
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Ex Vivo Lung Perfusion (EVLP) appears to be an effective strategy to expand the lung donor pool by better evaluation and reconditioning of non standard grafts. Today, EVLP is clinical practice at the most active transplant centers in North America and Europe. The aim of this observational prospective monocentric study is to prove the safety and efficacy of EVLP performed in the setting of Bergamo lung transplant program. A statistically estimated sample size would not fit with the small numbers of Italian lung transplant activity, so the investigators decided to enrol 10 consecutive recipients of grafts subjected to EVLP. Non standard grafts from Brain Dead Donors (BDD) and Donors after Cardiac Death (DCD) and standard grafts that will undergo prolonged cold ischemic time will be selected for EVLP. The donor lung procurement operation will be done in the usual manner. The EVLP procedure will be performed in the operating theater of Papa Giovanni XXIII Hospital. The investigators decided to adopt Toronto protocol since it involves some lung protective strategies. EVLP will proceed over a period of at least 4 and not more than 6 hours. After 60, 120, 180 and 240 minutes from the start of EVLP the following parameters will be evaluated:

• ratio of the partial pressure of arterial oxygen to fraction of inspired oxygen (PO2/FiO2, mmHg)
• Pulmonary Vascular Resistance (PVR, dine\*s/cm5)
• Peak Inspiratory Pressure (PIP, cmH2O) and mean airways Pressure (Pawm, cmH2O)
• dynamic lung Compliance (Cpldyn, ml/ cmH2O)
• ΔPO2 = pulmonary vein PO2 - pulmonary artery PO2 (mmHg). Moreover, after 60 and 240 minutes from the start of EVLP a graft X-ray and a bronchoscopy will be performed. The lung graft will be accepted for transplantation if, after 240 minutes from the start of EVLP, the following conditions are fulfilled:
• PO2/FiO2 \>350 mmHg
• stability or reduction of PVR compared with the measurement at the baseline assessment time point
• stability or reduction of PIP and Pawm compared with the measurement at the baseline assessment time point
• stable or better Cpldyn compared with the measurement at the baseline assessment time point
• ΔPO2 \>400 mmHg
• improvement of X-ray imaging compared with that at the baseline assessment time point
• exclusion of oedema and purulent secretions by bronchoscopy. After transplantation the recipients will be followed-up for 1 year according to a scheduled timetable. Data about the EVLP and transplant procedure and about the characteristics of donors and recipients will be collected in a dedicated electronic Case report form (eCRF) according to Good Clinical Practice.

Conditions

Ex Vivo Lung Perfusion; Lung Transplantation

Outcome Measures

Primary Outcomes (1)

• Grade of Primary Graft Dysfunction (PGD)

  Classification scheme proposed by the International Society for Heart and Lung Transplantation (ISHLT)

  72 hours after transplantation

Secondary Outcomes (7)

• Grade of PGD

  24 and 48 hours after transplantation

• Need for ECMO

  1 year after transplantation

• Length of ICU and hospital stay

  1 year after transplantation

• Duration of mechanical ventilation

  1 year after transplantation

• Incidence of anastomotic airway complications

  Up to 12 months after transplantation

Eligibility Criteria

• Age: 1 Month - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the patients on the waiting list for monolateral or bilateral lung transplantation at Bergamo lung transplant center

You may qualify if:

• lung transplant candidates who are going to be transplanted with grafts subjected to EVLP
• lung transplant candidates who consent to participate in the study by signing the informed consent form.

You may not qualify if:

• lung transplant candidates who are going to be transplanted with grafts not subjected to EVLP
• lung transplant candidates who are going to be transplanted with grafts subjected to EVLP but refuse consent for their participation in the study.

Sponsors & Collaborators

• Papa Giovanni XXIII Hospital: lead

Study Sites (1)

Papa Giovanni XXIII Hospital

Bergamo, 24127, Italy

Location

Study Officials

• Stefania Camagni, MD

  Papa Giovanni XXIII Hospital

  PRINCIPAL INVESTIGATOR

• Michele Colledan, MD

  Papa Giovanni XXIII Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 15, 2017
• Study Start: April 12, 2017
• Primary Completion: December 6, 2020
• Study Completion: December 6, 2020
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)