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Ex-Vivo Lung Perfusion to Increase the Number of Organs for Transplantation (EVLP_MI)

Primary Purpose

Disorder Related to Lung Transplantation, Brain Death, Graft Failure

Status
Completed
Phase
Phase 1
Locations
Italy
Study Type
Interventional
Intervention
EVLP Group
Sponsored by
Policlinico Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Disorder Related to Lung Transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria for donor lung:

  1. Recipient to undergo single or bilateral Lung Transplantation
  2. Donor arterial partial pressure of oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) below 300 mmHg, or doubtful donor lung function

Exclusion criteria for donor lung:

  1. Massive lung contusion
  2. Aspiration
  3. Pneumonia
  4. Sepsis
  5. Malignancy

Sites / Locations

  • Fondazione Ca' Granda IRCCS Ospedale Maggiore Policlinico

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Group

EVLP Group

Arm Description

Recipients of lungs procured from brain death donors deemed suitable for transplantation according to standard criteria. Events: lung procurement, cold storage on ice, transplantation.

Recipients of marginal lungs procured from brain death donors and reconditioned with ex-vivo lung perfusion (EVLP). Events: lung procurement, cold storage on ice, reconditioning by EVLP, cold storage on ice, transplantation.

Outcomes

Primary Outcome Measures

Primary Graft Dysfunction 72 hours after lung transplantation (PGD72)
Primary Graft Dysfunction 72 hours after transplantation (PGD72) definition: grade 3 according to the International Society of Heart and Lung Transplantation classification
30 day Mortality

Secondary Outcome Measures

Duration of mechanical ventilation after transplantation
ICU length of stay after transplantation

Full Information

First Posted
October 17, 2013
Last Updated
October 22, 2013
Sponsor
Policlinico Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01967953
Brief Title
Ex-Vivo Lung Perfusion to Increase the Number of Organs for Transplantation
Acronym
EVLP_MI
Official Title
Ex-Vivo Lung Perfusion to Improve Donor Lung Function and Increase the Number of Organs Available for Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Policlinico Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The recent introduction of ex-vivo lung perfusion (EVLP) as a tool to evaluate and recondition lungs from marginal donors has opened a new era in the field of lung transplantation.
Detailed Description
Aim of the investigation: to compare the clinical outcome after transplantation of subjects receiving marginal lungs procured from brain death donors and reconditioned by EVLP, with that of subjects receiving lungs procured from standard donors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder Related to Lung Transplantation, Brain Death, Graft Failure, Primary Graft Dysfunction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Group
Arm Type
No Intervention
Arm Description
Recipients of lungs procured from brain death donors deemed suitable for transplantation according to standard criteria. Events: lung procurement, cold storage on ice, transplantation.
Arm Title
EVLP Group
Arm Type
Experimental
Arm Description
Recipients of marginal lungs procured from brain death donors and reconditioned with ex-vivo lung perfusion (EVLP). Events: lung procurement, cold storage on ice, reconditioning by EVLP, cold storage on ice, transplantation.
Intervention Type
Procedure
Intervention Name(s)
EVLP Group
Intervention Description
EVLP technique: Steen solution; normothermia; low flow, open atrium, low hematocrit. Endpoints of EVLP assessment of lungs suitability: oxygenation, respiratory mechanics, pulmonary vascular resistance, chest X-ray, fibrobronchoscopy
Primary Outcome Measure Information:
Title
Primary Graft Dysfunction 72 hours after lung transplantation (PGD72)
Description
Primary Graft Dysfunction 72 hours after transplantation (PGD72) definition: grade 3 according to the International Society of Heart and Lung Transplantation classification
Time Frame
72 hours
Title
30 day Mortality
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Duration of mechanical ventilation after transplantation
Time Frame
30 days
Title
ICU length of stay after transplantation
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria for donor lung: Recipient to undergo single or bilateral Lung Transplantation Donor arterial partial pressure of oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) below 300 mmHg, or doubtful donor lung function Exclusion criteria for donor lung: Massive lung contusion Aspiration Pneumonia Sepsis Malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franco Valenza, MD
Organizational Affiliation
Fondazione Ca' Granda IRCCS Ospedale Maggiore Policlinico Milan Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione Ca' Granda IRCCS Ospedale Maggiore Policlinico
City
Milan
ZIP/Postal Code
20122
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
21488765
Citation
Cypel M, Yeung JC, Liu M, Anraku M, Chen F, Karolak W, Sato M, Laratta J, Azad S, Madonik M, Chow CW, Chaparro C, Hutcheon M, Singer LG, Slutsky AS, Yasufuku K, de Perrot M, Pierre AF, Waddell TK, Keshavjee S. Normothermic ex vivo lung perfusion in clinical lung transplantation. N Engl J Med. 2011 Apr 14;364(15):1431-40. doi: 10.1056/NEJMoa1014597.
Results Reference
background
PubMed Identifier
17184674
Citation
Oto T, Levvey BJ, Whitford H, Griffiths AP, Kotsimbos T, Williams TJ, Snell GI. Feasibility and utility of a lung donor score: correlation with early post-transplant outcomes. Ann Thorac Surg. 2007 Jan;83(1):257-63. doi: 10.1016/j.athoracsur.2006.07.040.
Results Reference
background
PubMed Identifier
15848310
Citation
Aigner C, Winkler G, Jaksch P, Seebacher G, Lang G, Taghavi S, Wisser W, Klepetko W. Extended donor criteria for lung transplantation--a clinical reality. Eur J Cardiothorac Surg. 2005 May;27(5):757-61. doi: 10.1016/j.ejcts.2005.01.024.
Results Reference
background
PubMed Identifier
17532422
Citation
Steen S, Ingemansson R, Eriksson L, Pierre L, Algotsson L, Wierup P, Liao Q, Eyjolfsson A, Gustafsson R, Sjoberg T. First human transplantation of a nonacceptable donor lung after reconditioning ex vivo. Ann Thorac Surg. 2007 Jun;83(6):2191-4. doi: 10.1016/j.athoracsur.2007.01.033.
Results Reference
background
PubMed Identifier
22386450
Citation
Valenza F, Rosso L, Coppola S, Froio S, Colombo J, Dossi R, Fumagalli J, Salice V, Pizzocri M, Conte G, Gatti S, Santambrogio L, Gattinoni L. beta-adrenergic agonist infusion during extracorporeal lung perfusion: effects on glucose concentration in the perfusion fluid and on lung function. J Heart Lung Transplant. 2012 May;31(5):524-30. doi: 10.1016/j.healun.2012.02.001. Epub 2012 Mar 3.
Results Reference
background
PubMed Identifier
16678604
Citation
Botha P, Trivedi D, Weir CJ, Searl CP, Corris PA, Dark JH, Schueler SV. Extended donor criteria in lung transplantation: impact on organ allocation. J Thorac Cardiovasc Surg. 2006 May;131(5):1154-60. doi: 10.1016/j.jtcvs.2005.12.037.
Results Reference
background
PubMed Identifier
21620034
Citation
Valenza F, Rosso L, Pizzocri M, Salice V, Umbrello M, Conte G, Stanzi A, Colombo J, Gatti S, Santambrogio L, Iapichino G, Gattinoni L. The consumption of glucose during ex vivo lung perfusion correlates with lung edema. Transplant Proc. 2011 May;43(4):993-6. doi: 10.1016/j.transproceed.2011.01.122.
Results Reference
background
PubMed Identifier
24628890
Citation
Valenza F, Rosso L, Coppola S, Froio S, Palleschi A, Tosi D, Mendogni P, Salice V, Ruggeri GM, Fumagalli J, Villa A, Nosotti M, Santambrogio L, Gattinoni L. Ex vivo lung perfusion to improve donor lung function and increase the number of organs available for transplantation. Transpl Int. 2014 Jun;27(6):553-61. doi: 10.1111/tri.12295. Epub 2014 Apr 4.
Results Reference
derived
Links:
URL
http://nlm.nih.gov/medlineplus/
Description
Lung transplantation

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Ex-Vivo Lung Perfusion to Increase the Number of Organs for Transplantation

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