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

• Sponsor: Policlinico Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01967953
• Collaborator: (none)
• Enrollment: 7
• Location: 1
• Arms: 2
• Duration (Months): 28
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Disorder Related to Lung Transplantation; Brain Death; Graft Failure; Primary Graft Dysfunction	Procedure: EVLP Group	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Ex-Vivo Lung Perfusion to Improve Donor Lung Function and Increase the Number of Organs Available for Transplantation
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard Group Recipients of lungs procured from brain death donors deemed suitable for transplantation according to standard criteria. Events: lung procurement, cold storage on ice, transplantation.
Experimental: EVLP Group 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.	Procedure: EVLP Group; 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

Outcome Measures

Primary Outcome Measures

1. Primary Graft Dysfunction 72 hours after lung transplantation (PGD72) [72 hours]

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

2. 30 day Mortality [30 days]

Secondary Outcome Measures

1. Duration of mechanical ventilation after transplantation [30 days]

2. ICU length of stay after transplantation [30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Ca' Granda IRCCS Ospedale Maggiore Policlinico	Milan		Italy	20122

Sponsors and Collaborators

• Policlinico Hospital

Investigators

• Principal Investigator: Franco Valenza, MD, Fondazione Ca' Granda IRCCS Ospedale Maggiore Policlinico Milan Italy

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Lung transplantation

Publications

• 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.
• 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.
• 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.
• 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.
• Steen S, Ingemansson R, Eriksson L, Pierre L, Algotsson L, Wierup P, Liao Q, Eyjolfsson A, Gustafsson R, Sjöberg T. First human transplantation of a nonacceptable donor lung after reconditioning ex vivo. Ann Thorac Surg. 2007 Jun;83(6):2191-4.
• 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. β-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.
• 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.

• Responsible Party: Franco Valenza, MD, Assistant Professor Anaesthesia and Intensive Care, Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Policlinico Hospital
• ClinicalTrials.gov Identifier: NCT01967953
• Other Study ID Numbers: EVLP_2011
• First Posted: Oct 23, 2013
• Last Update Posted: Oct 23, 2013
• Last Verified: Oct 1, 2013

• Additional relevant MeSH terms: Brain Death; Primary Graft Dysfunction

Study Results

No Results Posted as of Oct 23, 2013