NCT01967953

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 23, 2013

Completed
Last Updated

October 23, 2013

Status Verified

October 1, 2013

Enrollment Period

2.3 years

First QC Date

October 17, 2013

Last Update Submit

October 22, 2013

Conditions

Disorder Related to Lung TransplantationBrain DeathGraft FailurePrimary Graft Dysfunction

Outcome Measures

Primary Outcomes (2)

  • 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

    72 hours

  • 30 day Mortality

    30 days

Secondary Outcomes (2)

  • Duration of mechanical ventilation after transplantation

    30 days

  • ICU length of stay after transplantation

    30 days

Study Arms (2)

Standard Group

NO INTERVENTION

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

EVLP Group

EXPERIMENTAL

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

Interventions

EVLP GroupPROCEDURE

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

EVLP Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Massive lung contusion
  • Aspiration
  • Pneumonia
  • Sepsis
  • Malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Ca' Granda IRCCS Ospedale Maggiore Policlinico

Milan, Italy, 20122, Italy

Location

Related Publications (8)

  • 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.

    PMID: 21488765BACKGROUND

  • 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.

    PMID: 17184674BACKGROUND

  • 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.

    PMID: 15848310BACKGROUND

  • 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.

    PMID: 17532422BACKGROUND

  • 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.

    PMID: 22386450BACKGROUND

  • 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.

    PMID: 16678604BACKGROUND

  • 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.

    PMID: 21620034BACKGROUND

  • 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.

    PMID: 24628890DERIVED

MeSH Terms

Conditions

Brain DeathPrimary Graft Dysfunction

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesComaUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsDeathPathologic ProcessesPathological Conditions, Signs and SymptomsReperfusion InjuryVascular DiseasesCardiovascular DiseasesPostoperative Complications

Study Officials

  • Franco Valenza, MD

    Fondazione Ca' Granda IRCCS Ospedale Maggiore Policlinico Milan Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Anaesthesia and Intensive Care, Department of Pathophysiology and Transplantation, Università degli Studi di Milano

Study Record Dates

First Submitted

October 17, 2013

First Posted

October 23, 2013

Study Start

January 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

October 23, 2013

Record last verified: 2013-10

Locations

IT(1)