NCT03053349

Ex Vivo Lung Perfusion in Bergamo Lung Transplant Program

Completed Last updated 23 May 2023

What this trial tests

trial in Ex Vivo Lung Perfusion in 10 participants. Completed in 6 December 2020.

Timeline

12 April 2017

Primary endpoint
6 December 2020

6 December 2020

Quick facts

Lead sponsor	Papa Giovanni XXIII Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	10
Start date	12 April 2017
Primary completion	6 December 2020
Estimated completion	6 December 2020
Sites	1 location across Italy

Conditions studied

• Ex Vivo Lung Perfusion — all drugs for Ex Vivo Lung Perfusion →
• Lung Transplantation — all drugs for Lung Transplantation →

Sponsor

Papa Giovanni XXIII Hospital

Who can join

Adults 1 Month to 70, any sex, with Ex Vivo Lung Perfusion or Lung Transplantation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.