Normothermic Ex Vivo Lung Perfusion (EVLP) For An Improved Assessment of Donor Lungs For Transplantation - Full Text View

Purpose

The use of ex vivo lung perfusion (EVLP) will allow for a secondary evaluation technique for donor lungs that fail to meet standard acceptability criteria. This advanced assessment might lead to increased utilization rates of donor lungs and improved outcomes after lung transplantation.

Condition	Intervention	Phase
Lung Transplantation	Drug: Ex vivo lung perfusion with Steen Solution™	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Normothermic Ex Vivo Lung Perfusion (EVLP) For An Improved Assessment of Donor Lungs For Transplantation

Resource links provided by NLM:

MedlinePlus related topics: Lung Transplantation

U.S. FDA Resources

Further study details as provided by XVIVO Perfusion:

Primary Outcome Measures:

PGD scores in the first 72 hours after lung transplantation. [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
Immediate lung function is one of the key factors in determining the impact of donor lung quality, therefore the PGD score within 72 hrs was selected as the primary endpoint.
30 day Mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Mortality at 30 days post transplant

Secondary Outcome Measures:

Extra-corporeal membrane oxygenation use [ Time Frame: 30 days ] [ Designated as safety issue: No ]
If the patient needed to be placed on extra-corporeal membrane oxygenation after transplantation.
Bronchial complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
To see if there was an increased risk for bronchial complications
Ventilator duration [ Time Frame: 30 days ] [ Designated as safety issue: No ]
How long was the patient on the ventilator after lung transplantation and was there an increased time on ventilator for the patient after EVLP.
Intensive Care Unit length of stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Hospital length of stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Time in the hospital

Enrollment:	22
Study Start Date:	August 2008
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: EVLP Group EVLP Group are those recipient lung transplant patients that received donor lungs that had been placed on the ex vivo lung perfusion system with Steen Solution™ .	Drug: Ex vivo lung perfusion with Steen Solution™ The circuit is primed with 2,000cc Steen Solution™. At one hour of EVLP, 500 cc of circulated perfusate was removed and replenished with 500 cc of fresh perfusate. After that, 250 cc of perfusate was exchanged every hour.

Detailed Description:

Human donor lungs that do not meet the standard clinical criteria for donor lung utilization but fit into the study inclusion criteria will be retrieved from the donor using current donor lung retrieval techniques.

These lungs will be brought to the study transplant center to be re-assessed by the transplant team. The lungs will be physiologically assessed during ex vivo perfusion with Steen Solution. Perfusion of these lungs will be performed using Steen solution with the addition of methylprednisolone, heparin and antibiotics. With respect to the decision of lung utilization those organs with a delta pO2 (Δ pO2 = Pulmonary vein pO2 - pulmonary artery pO2) during ex vivo perfusion assessment > 350mmHg, good lung compliance, and a favorable opinion of the transplant surgeon will be considered transplantable. Lungs will be excluded for transplantation: if the Δ pO2 is less than 350mmHg or if they demonstrate >10% deterioration in any of the following functional parameters: pulmonary vascular resistance (PVR), dynamic compliance or airway pressures. Lungs will also be excluded if they are deemed unsuitable based on the clinical judgment of the lung transplant surgeon.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria for donor lung:

Recipient to undergo a single or bilateral Lung Transplantation
Last donor PaO2/FiO2 ≤ 300mmHg
Poor oxygenation and/or poor lung compliance is the primary reason for unsuitability
Absence of pneumonia, persistent purulent secretion on bronchoscopy or significant mechanical trauma

Exclusion Criteria:

Infection
Aspiration
Significant mechanical lung injury - contusion
Infectious diseases : HIV, Hepatitis B and C, HTLV & Syphilis
Malignancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190059

Locations

Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 1Z5

Sponsors and Collaborators

XVIVO Perfusion

Investigators

Principal Investigator:

Shaf Keshavjee, MD,MSc,FRCSC

University of Toronto-Toronto General Hospital

More Information

Publications:

Pierre AF, Sekine Y, Hutcheon MA, Waddell TK, Keshavjee SH. Marginal donor lungs: a reassessment. J Thorac Cardiovasc Surg. 2002 Mar;123(3):421-7; discussion, 427-8.

de Perrot M, Liu M, Waddell TK, Keshavjee S. Ischemia-reperfusion-induced lung injury. Am J Respir Crit Care Med. 2003 Feb 15;167(4):490-511. Review.

Cypel M, Rubacha M, Yeung J, Hirayama S, Torbicki K, Madonik M, Fischer S, Hwang D, Pierre A, Waddell TK, de Perrot M, Liu M, Keshavjee S. Normothermic ex vivo perfusion prevents lung injury compared to extended cold preservation for transplantation. Am J Transplant. 2009 Oct;9(10):2262-9. Epub 2009 Aug 6.

Inci I, Ampollini L, Arni S, Jungraithmayr W, Inci D, Hillinger S, Leskosek B, Vogt P, Weder W. Ex vivo reconditioning of marginal donor lungs injured by acid aspiration. J Heart Lung Transplant. 2008 Nov;27(11):1229-36. Epub 2008 Oct 1.

Steen S, Sjöberg T, Pierre L, Liao Q, Eriksson L, Algotsson L. Transplantation of lungs from a non-heart-beating donor. Lancet. 2001 Mar 17;357(9259):825-9.

Ingemansson R, Eyjolfsson A, Mared L, Pierre L, Algotsson L, Ekmehag B, Gustafsson R, Johnsson P, Koul B, Lindstedt S, Lührs C, Sjöberg T, Steen S. Clinical transplantation of initially rejected donor lungs after reconditioning ex vivo. Ann Thorac Surg. 2009 Jan;87(1):255-60.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Dr. Shaf Keshavjee, University of Toronto-Toronto General Hospital
ClinicalTrials.gov Identifier:	NCT01190059 History of Changes
Other Study ID Numbers:	VIT-001-TOR, 139150
Study First Received:	August 25, 2010
Last Updated:	November 12, 2010
Health Authority:	Canada: Health Canada

Keywords provided by XVIVO Perfusion:

Lung
Transplantation
Lung Transplantation
Transplantation Lung

ClinicalTrials.gov processed this record on May 19, 2013

Normothermic Ex Vivo Lung Perfusion (EVLP) For An Improved Assessment of Donor Lungs For Transplantation (HELP)