NCT02234128

Brief Summary

This is a safety study to compare the safety of receiving a lung treated with the Toronto EVLP System™ by SPONSOR in SPONSOR's dedicated facility against standard lung transplantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

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

First Submitted

Initial submission to the registry

September 4, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
10 months until next milestone

Study Start

First participant enrolled

July 18, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2018

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2019

Completed
11 months until next milestone

Results Posted

Study results publicly available

October 9, 2020

Completed
Last Updated

December 2, 2020

Status Verified

November 1, 2020

Enrollment Period

3.3 years

First QC Date

September 4, 2014

Results QC Date

August 18, 2020

Last Update Submit

November 16, 2020

Conditions

Lung Disease

Keywords

Ex Vivo Lung PerfusionEVLPLung TransplantLung TransplantationToronto EVLP System™PERFUSIX

Outcome Measures

Primary Outcomes (2)

  • Count of Participants With Primary Graft Dysfunction (PGD), Grade 3

    Primary Graft Dysfunction is a scale published by the International Society of Heart and Lung Transplantation that uses patient oxygenation and radiographic results to score patients on a 0 (zero) to 3 (three) scale, with 3 being the most significant dysfunction.

    72 Hours

  • Count of Participants Surviving

    The number of participants that survived to 30 days post-transplant.

    30 Days

Secondary Outcomes (5)

  • PGD Score

    0, 24, 48 & 72 Hours

  • ICU Length of Stay

    30 Days

  • Total Lung Preservation Time (TPT)

    72 Hours

  • Time to First Extubation

    Days

  • Hospital Length of Stay

    Days

Study Arms (3)

EVLP Double Lung Group

EXPERIMENTAL

Toronto EVLP System™ administered to double lungs.

Device: Toronto EVLP System™

EVLP Single Lung Group

EXPERIMENTAL

Toronto EVLP System™ administered to single lungs.

Device: Toronto EVLP System™

Control Group

NO INTERVENTION

Those patients receiving a single or double lung via conventional transplant.

Interventions

Toronto EVLP System™DEVICE

Extending preservation and assessment time of donor lungs using the Toronto EVLP System

EVLP Double Lung GroupEVLP Single Lung Group

Eligibility Criteria

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

You may qualify if:

  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • Male or female patients
  • All patients, 18 years of age or older
  • Patient already on or added to the active waiting list for a single or bilateral lung transplant
  • Patient or patient's representative provides informed consent for participation in the study at the time of study commencement or time of listing for transplant
  • Patient or patient's representative reconfirms informed consent for the study on the day of lung transplant

You may not qualify if:

  • A subject who meets any of the following criteria will be excluded from participation:
  • Patients listed for same-side lung re-transplantation
  • Patients listed for multiple organ transplantation including lung and any other organ
  • Patients listed for live donor lobar transplant
  • Patients with HIV, active Hepatitis B/C, or Burkholderia Cepacia
  • Patients not initially consented into the study prior to the time of lung transplant
  • Patients in the ICU at the time of initial lung offer requiring mechanical ventilation, ECMO or other Extracorporeal life support (ECLS).
  • The donor lung must meet at least one of the following criteria to proceed with EVLP:
  • At the time of the clinical evaluation, the donor PaO2/FiO2 \< 300 mmHg
  • Donor received ≥ 10 units of blood transfusions
  • Donation after Cardiac Death (DCD) donor
  • Expected cold ischemic time \> 6 hours
  • Donor age ≥ 55 years old
  • Study Center Investigator requires additional assessment ex vivo and/or extended preservation time
  • The donor lung is excluded from EVLP if at least one of the following criteria have been met:
  • +25 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Loyola University Medical Center

Chicago, Illinois, 60153, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Duke University Health System

Durham, North Carolina, 27705, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

Location

Related Publications (25)

  • 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: 11882811BACKGROUND

  • Ware LB, Wang Y, Fang X, Warnock M, Sakuma T, Hall TS, Matthay M. Assessment of lungs rejected for transplantation and implications for donor selection. Lancet. 2002 Aug 24;360(9333):619-20. doi: 10.1016/s0140-6736(02)09774-x.

    PMID: 12241936BACKGROUND

  • Orens JB, Boehler A, de Perrot M, Estenne M, Glanville AR, Keshavjee S, Kotloff R, Morton J, Studer SM, Van Raemdonck D, Waddel T, Snell GI; Pulmonary Council, International Society for Heart and Lung Transplantation. A review of lung transplant donor acceptability criteria. J Heart Lung Transplant. 2003 Nov;22(11):1183-200. doi: 10.1016/s1053-2498(03)00096-2. No abstract available.

    PMID: 14585380BACKGROUND

  • Kawut SM, Reyentovich A, Wilt JS, Anzeck R, Lederer DJ, O'Shea MK, Sonett JR, Arcasoy SM. Outcomes of extended donor lung recipients after lung transplantation. Transplantation. 2005 Feb 15;79(3):310-6. doi: 10.1097/01.tp.0000149504.53710.ae.

    PMID: 15699761BACKGROUND

  • Christie JD, Carby M, Bag R, Corris P, Hertz M, Weill D; ISHLT Working Group on Primary Lung Graft Dysfunction. Report of the ISHLT Working Group on Primary Lung Graft Dysfunction part II: definition. A consensus statement of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2005 Oct;24(10):1454-9. doi: 10.1016/j.healun.2004.11.049. Epub 2005 Jun 4. No abstract available.

    PMID: 16210116BACKGROUND

  • 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

  • Avlonitis VS, Wigfield CH, Golledge HD, Kirby JA, Dark JH. Early hemodynamic injury during donor brain death determines the severity of primary graft dysfunction after lung transplantation. Am J Transplant. 2007 Jan;7(1):83-90. doi: 10.1111/j.1600-6143.2006.01593.x.

    PMID: 17227559BACKGROUND

  • Suzuki Y, Cantu E, Christie JD. Primary graft dysfunction. Semin Respir Crit Care Med. 2013 Jun;34(3):305-319. doi: 10.1055/s-0033-1348474. Epub 2013 Jul 2.

    PMID: 23821506BACKGROUND

  • Bennett M, Horton S, Thuys C, Augustin S, Rosenberg M, Brizard C. Pump-induced haemolysis: a comparison of short-term ventricular assist devices. Perfusion. 2004 Mar;19(2):107-11. doi: 10.1191/0267659104pf729oa.

    PMID: 15162925BACKGROUND

  • Watanabe N, Sakota D, Ohuchi K, Takatani S. Deformability of red blood cells and its relation to blood trauma in rotary blood pumps. Artif Organs. 2007 May;31(5):352-8. doi: 10.1111/j.1525-1594.2007.00392.x.

    PMID: 17470204BACKGROUND

  • Lyu DM, Zamora MR. Medical complications of lung transplantation. Proc Am Thorac Soc. 2009 Jan 15;6(1):101-7. doi: 10.1513/pats.200808-077GO.

    PMID: 19131535BACKGROUND

  • Cypel M, Yeung JC, Hirayama S, Rubacha M, Fischer S, Anraku M, Sato M, Harwood S, Pierre A, Waddell TK, de Perrot M, Liu M, Keshavjee S. Technique for prolonged normothermic ex vivo lung perfusion. J Heart Lung Transplant. 2008 Dec;27(12):1319-25. doi: 10.1016/j.healun.2008.09.003.

    PMID: 19059112BACKGROUND

  • 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: 19663886BACKGROUND

  • Cypel M, Liu M, Rubacha M, Yeung JC, Hirayama S, Anraku M, Sato M, Medin J, Davidson BL, de Perrot M, Waddell TK, Slutsky AS, Keshavjee S. Functional repair of human donor lungs by IL-10 gene therapy. Sci Transl Med. 2009 Oct 28;1(4):4ra9. doi: 10.1126/scitranslmed.3000266.

    PMID: 20368171BACKGROUND

  • Cypel M, Sato M, Yildirim E, Karolak W, Chen F, Yeung J, Boasquevisque C, Leist V, Singer LG, Yasufuku K, Deperrot M, Waddell TK, Keshavjee S, Pierre A. Initial experience with lung donation after cardiocirculatory death in Canada. J Heart Lung Transplant. 2009 Aug;28(8):753-8. doi: 10.1016/j.healun.2009.05.009. Epub 2009 Jun 28.

    PMID: 19632569BACKGROUND

  • Yeung JC, Cypel M, Waddell TK, van Raemdonck D, Keshavjee S. Update on donor assessment, resuscitation, and acceptance criteria, including novel techniques--non-heart-beating donor lung retrieval and ex vivo donor lung perfusion. Thorac Surg Clin. 2009 May;19(2):261-74. doi: 10.1016/j.thorsurg.2009.02.006.

    PMID: 19662970BACKGROUND

  • 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

  • Cypel M, Yeung JC, Keshavjee S. Novel approaches to expanding the lung donor pool: donation after cardiac death and ex vivo conditioning. Clin Chest Med. 2011 Jun;32(2):233-44. doi: 10.1016/j.ccm.2011.02.003. Epub 2011 Mar 25.

    PMID: 21511086BACKGROUND

  • Koike T, Yeung JC, Cypel M, Rubacha M, Matsuda Y, Sato M, Waddell TK, Liu M, Keshavjee S. Kinetics of lactate metabolism during acellular normothermic ex vivo lung perfusion. J Heart Lung Transplant. 2011 Dec;30(12):1312-9. doi: 10.1016/j.healun.2011.07.014. Epub 2011 Sep 17.

    PMID: 21930395BACKGROUND

  • Cypel M, Yeung JC, Machuca T, Chen M, Singer LG, Yasufuku K, de Perrot M, Pierre A, Waddell TK, Keshavjee S. Experience with the first 50 ex vivo lung perfusions in clinical transplantation. J Thorac Cardiovasc Surg. 2012 Nov;144(5):1200-6. doi: 10.1016/j.jtcvs.2012.08.009. Epub 2012 Aug 31.

    PMID: 22944089BACKGROUND

  • Yeung JC, Cypel M, Machuca TN, Koike T, Cook DJ, Bonato R, Chen M, Sato M, Waddell TK, Liu M, Slutsky AS, Keshavjee S. Physiologic assessment of the ex vivo donor lung for transplantation. J Heart Lung Transplant. 2012 Oct;31(10):1120-6. doi: 10.1016/j.healun.2012.08.016.

    PMID: 22975103BACKGROUND

  • Wigfield CH, Cypel M, Yeung J, Waddell T, Alex C, Johnson C, Keshavjee S, Love RB. Successful emergent lung transplantation after remote ex vivo perfusion optimization and transportation of donor lungs. Am J Transplant. 2012 Oct;12(10):2838-44. doi: 10.1111/j.1600-6143.2012.04175.x.

    PMID: 23009140BACKGROUND

  • Cypel M, Keshavjee S. The clinical potential of ex vivo lung perfusion. Expert Rev Respir Med. 2012 Feb;6(1):27-35. doi: 10.1586/ers.11.93.

    PMID: 22283576BACKGROUND

  • Munshi L, Keshavjee S, Cypel M. Donor management and lung preservation for lung transplantation. Lancet Respir Med. 2013 Jun;1(4):318-28. doi: 10.1016/S2213-2600(12)70064-4. Epub 2013 Feb 20.

    PMID: 24429157BACKGROUND

  • Mallea JM, Hartwig MG, Keller CA, Kon Z, Iii RNP, Erasmus DB, Roberts M, Patzlaff NE, Johnson D, Sanchez PG, D'Cunha J, Brown AW, Dilling DF, McCurry K. Remote ex vivo lung perfusion at a centralized evaluation facility. J Heart Lung Transplant. 2022 Dec;41(12):1700-1711. doi: 10.1016/j.healun.2022.09.006. Epub 2022 Sep 18.

    PMID: 36229329DERIVED

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Results Point of Contact

Title
Michael Roberts, Director Regulatory Affairs
Organization
Lung Bioengineering Inc.
mroberts@lungbioengineering.com
2406502261

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2014

First Posted

September 9, 2014

Study Start

July 18, 2015

Primary Completion

November 21, 2018

Study Completion

November 7, 2019

Last Updated

December 2, 2020

Results First Posted

October 9, 2020

Record last verified: 2020-11

Locations

US(8)