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

NCT01190059 | Completed Phase 1 DMC

• 2 other identifiers: VIT-001-TOR139150
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Transplantation

Keywords

Lung; Transplantation; Lung Transplantation; Transplantation Lung

Outcome Measures

Primary Outcomes (2)

• PGD scores in the first 72 hours after lung transplantation.

  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.

  72 hours

• 30 day Mortality

  Mortality at 30 days post transplant

  30 days

Secondary Outcomes (5)

• Extra-corporeal membrane oxygenation use

  30 days

• Bronchial complications

  30 days

• Ventilator duration

  30 days

• Intensive Care Unit length of stay

  30 days

• Hospital length of stay

  30 days

Study Arms (1)

EVLP Group

EXPERIMENTAL

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™

Interventions

Ex vivo lung perfusion with Steen Solution™ DRUG

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.

EVLP Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• XVIVO Perfusion: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 1Z5, Canada

Location

Related Publications (9)

• 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. doi: 10.1067/mtc.2002.120345.

  PMID: 11882811 BACKGROUND

• 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. doi: 10.1164/rccm.200207-670SO.

  PMID: 12588712 BACKGROUND

• 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. doi: 10.1111/j.1600-6143.2009.02775.x. Epub 2009 Aug 6.

  PMID: 19663886 BACKGROUND

• D.M. Karamanou, H.R. Walden, S. Bean, et al. The Effect of Ex-Vivo Perfusion on the Inflammatory Profile of the Donor Lung. J Heart Lung Transplant 2010:Vol. 29, Issue 2, Supplement, Page S165.

  BACKGROUND

• 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. doi: 10.1016/j.healun.2008.07.027. Epub 2008 Oct 1.

  PMID: 18971096 BACKGROUND

• Steen S, Sjoberg 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. doi: 10.1016/S0140-6736(00)04195-7.

  PMID: 11265950 BACKGROUND

• Ingemansson R, Eyjolfsson A, Mared L, Pierre L, Algotsson L, Ekmehag B, Gustafsson R, Johnsson P, Koul B, Lindstedt S, Luhrs C, Sjoberg T, Steen S. Clinical transplantation of initially rejected donor lungs after reconditioning ex vivo. Ann Thorac Surg. 2009 Jan;87(1):255-60. doi: 10.1016/j.athoracsur.2008.09.049.

  PMID: 19101308 BACKGROUND

• 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: 17532422 BACKGROUND

• 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: 21488765 DERIVED

Study Officials

• Shaf Keshavjee, MD,MSc,FRCSC

  University of Toronto / Toronto General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2010
• First Posted: August 27, 2010
• Study Start: August 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

CA (1)