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Trial record 15 of 20 for:    evlp

Ex Vivo Lung Perfusion in Bergamo Lung Transplant Program

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ClinicalTrials.gov Identifier: NCT03053349
Recruitment Status : Recruiting
First Posted : February 15, 2017
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Stefania Camagni, Papa Giovanni XXIII Hospital

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.


Condition or disease
Ex Vivo Lung Perfusion Lung Transplantation

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Ex Vivo Lung Perfusion in Bergamo Lung Transplant Program: A Prospective Observational Study
Actual Study Start Date : February 18, 2017
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Grade of Primary Graft Dysfunction (PGD) [ Time Frame: 72 hours after transplantation ]
    Classification scheme proposed by the International Society for Heart and Lung Transplantation (ISHLT)


Secondary Outcome Measures :
  1. Grade of PGD [ Time Frame: 24 and 48 hours after transplantation ]
    Classification scheme proposed by the ISHLT

  2. Need for ECMO [ Time Frame: 1 year after transplantation ]
    Use of post-operative ECMO to support lung and/or heart function (yes/no)

  3. Length of ICU and hospital stay [ Time Frame: 1 year after transplantation ]
    Length of ICU and hospital stay after transplantation (days)

  4. Duration of mechanical ventilation [ Time Frame: 1 year after transplantation ]
    Duration of mechanical ventilation after transplantation (days)

  5. Incidence of anastomotic airway complications [ Time Frame: Up to 12 months after transplantation ]
    MDS endoscopic standardized grading system for macroscopic central airway complications after lung transplantation

  6. 30-day mortality [ Time Frame: 30 days after transplantation ]
    Mortality rate 30 days after transplantation

  7. 1-year patient survival [ Time Frame: 1 year after transplantation ]
    Patient survival rate 1 year after transplantation



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Recipients' Inclusion Criteria:

  • 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.

Recipients' Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053349


Contacts
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Contact: Stefania Camagni, MD 0039 035 2674347 scamagni@asst-pg23.it

Locations
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Italy
Papa Giovanni XXIII Hospital Recruiting
Bergamo, Italy, 24127
Contact: Stefania Camagni, MD       scamagni@asst-pg23.it   
Sponsors and Collaborators
Papa Giovanni XXIII Hospital
Investigators
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Principal Investigator: Stefania Camagni, MD Papa Giovanni XXIII Hospital
Study Director: Michele Colledan, MD Papa Giovanni XXIII Hospital

Additional Information:

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Responsible Party: Stefania Camagni, MD, Papa Giovanni XXIII Hospital
ClinicalTrials.gov Identifier: NCT03053349     History of Changes
Other Study ID Numbers: EVLP Bergamo - nr 2016-0194
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No