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Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability

This study has suspended participant recruitment.
(Funding suspended, currently seeking other funding source(s).)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01615484
First Posted: June 8, 2012
Last Update Posted: July 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Vitrolife
XVIVO Perfusion
Information provided by (Responsible Party):
Tom Egan, MD,MsC, University of North Carolina, Chapel Hill
  Purpose
The purpose of this research study is to learn about the safety of transplanting lungs obtained from non-heart-beating donors (NHBDs) that have been ventilated (attached to a breathing machine or ventilator to deliver oxygen) and perfused with a lung perfusion solution (Steen solution™, made by Vitrolife). This ventilation and perfusion will be done outside the body (ex-vivo) in a modified cardiopulmonary bypass circuit (the kind of device used routinely during most heart surgeries). The purpose of performing ex-vivo perfusion and ventilation is to learn how well the lungs work, and whether they are likely safe to transplant.

Condition Intervention Phase
Emphysema Chronic Obstructive Pulmonary Disease (COPD) Cystic Fibrosis Pulmonary Fibrosis Bronchiectasis Sarcoidosis Pulmonary Hypertension Alpha-1 Antitrypsin Deficiency Procedure: Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ Device: STEEN Solution™ Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability

Resource links provided by NLM:


Further study details as provided by Tom Egan, MD,MsC, University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 30 Day Mortality and Graft Survival [ Time Frame: 30 Days ]
    The primary objective evaluated for this study is recipient mortality and graft survival at 30 days post transplant. 30 day mortality and graft survival is used as a standard research assessment to evaluate post transplant outcomes.

  • Primary Lung Graft Dysfunction (PGD) [ Time Frame: 24 and 72 hours ]
    Primary Lung Graft Dysfunction (PGD) is an indicator for significant morbidity and mortality after lung transplantation.


Secondary Outcome Measures:
  • ICU Length of Stay [ Time Frame: Time to Discharge. ]
    The length of ICU stay is another standard research and clinical outcome assessment post transplant and has been selected as a secondary objective.

  • Day 7 Ventilator/ECMO Status [ Time Frame: 7 Days Post Transplant. ]
    7 days ventilator or extra-corporeal membrane oxygenator (ECMO) free are being evaluated as secondary objectives.

  • Recipient mortality at 12 months. [ Time Frame: 12 months ]
    Recipient mortality at 12 months post transplant is being evaluated as a secondary objective.

  • Bronchiolitis Obliterans Syndrome (BOS) free graft survival. [ Time Frame: 12 Months ]
    Bronchiolitis Obliterans Syndrome (BOS) free graft survival at 12 months is being used as a secondary outcome.


Estimated Enrollment: 10
Study Start Date: September 2013
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ex-vivo lung perfusion with STEEN Solution™
The perfusion of the lungs will be performed using STEEN Solution™. The lungs will be physiologically assessed during ex vivo perfusion with STEEN Solution™ perfusate.
Procedure: Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™
After EVLP, lungs will be cooled in the circuit to room temperature, then flushed with cold Perfadex™, and taken to UNCH where they will have an ex-vivo CT scan. Lungs determined suitable will be offered to consented patients at UNC Hospitals and Duke University Medical Center based on Lung Allocation Score. Lungs not considered for transplantation may be subjected to different experiments but are not to be a part of this research study. In summary, lungs with good and stable function during EVLP will be transplanted into recipients as per current clinical practice.
Device: STEEN Solution™
This solution is a buffered dextran and albumin-containing extracellular perfusate with an optimal colloid osmotic pressure developed specifically for extra-corporeal perfusion of lungs.
No Intervention: Lung transplant from conventional brain-dead organ donor
No experimental procedures will be carried out.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A recipient must meet the following requirement to enroll into the study:
  • Requires a single or bilateral lung transplant and is listed for transplant at UNC or Duke
  • Male or Female, 15 years of age or older.
  • Subject or Subject's Representative provides a legally effective informed consent.
  • Recipient does not have HIV, active Hepatitis or is colonized with Burkholderia cepacia.
  • Potential subjects who have undergone previous lung transplants and meet all other inclusion criteria, are eligible for study participation.

Exclusion Criteria:

•Recipient fails to meet standard of care requirements for lung transplant, or decides not to participate.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01615484


Locations
United States, North Carolina
UNC-Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Vitrolife
XVIVO Perfusion
Investigators
Principal Investigator: Thomas M. Egan, MD, MSc. UNC-Chapel Hill
  More Information

Publications:
Orens JB, Estenne M, Arcasoy S, Conte JV, Corris P, Egan JJ, Egan T, Keshavjee S, Knoop C, Kotloff R, Martinez FJ, Nathan S, Palmer S, Patterson A, Singer L, Snell G, Studer S, Vachiery JL, Glanville AR; Pulmonary Scientific Council of the International Society for Heart and Lung Transplantation. International guidelines for the selection of lung transplant candidates: 2006 update--a consensus report from the Pulmonary Scientific Council of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2006 Jul;25(7):745-55.
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. doi: 10.1016/j.athoracsur.2008.09.049.
Mason DP, Thuita L, Alster JM, Murthy SC, Budev MM, Mehta AC, Pettersson GB, Blackstone EH. Should lung transplantation be performed using donation after cardiac death? The United States experience. J Thorac Cardiovasc Surg. 2008 Oct;136(4):1061-6. doi: 10.1016/j.jtcvs.2008.04.023.
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.
Egan TM, Haithcock JA, Nicotra WA, Koukoulis G, Inokawa H, Sevala M, Molina PL, Funkhouser WK, Mattice BJ. Ex vivo evaluation of human lungs for transplant suitability. Ann Thorac Surg. 2006 Apr;81(4):1205-13.
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. Epub 2005 Jun 4.
Kim IK, Bedi DS, Denecke C, Ge X, Tullius SG. Impact of innate and adaptive immunity on rejection and tolerance. Transplantation. 2008 Oct 15;86(7):889-94. doi: 10.1097/TP.0b013e318186ac4a. Review.
Moers C, Smits JM, Maathuis MH, Treckmann J, van Gelder F, Napieralski BP, van Kasterop-Kutz M, van der Heide JJ, Squifflet JP, van Heurn E, Kirste GR, Rahmel A, Leuvenink HG, Paul A, Pirenne J, Ploeg RJ. Machine perfusion or cold storage in deceased-donor kidney transplantation. N Engl J Med. 2009 Jan 1;360(1):7-19. doi: 10.1056/NEJMoa0802289.
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.
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.

Responsible Party: Tom Egan, MD,MsC, Professor of Surgery, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01615484     History of Changes
Other Study ID Numbers: UNC-002 Vitrolife
1UM1HL113115-01A1 ( U.S. NIH Grant/Contract )
First Submitted: June 6, 2012
First Posted: June 8, 2012
Last Update Posted: July 12, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual clinical outcome data will be made available upon request

Keywords provided by Tom Egan, MD,MsC, University of North Carolina, Chapel Hill:
Lung Transplant
Emphysema
Chronic Obstructive Pulmonary Disease (COPD)
Cystic Fibrosis
Pulmonary Fibrosis
Bronchiectasis
Sarcoidosis
Pulmonary Hypertension
Alpha-1 Antitrypsin Deficiency

Additional relevant MeSH terms:
Hypertension
Lung Diseases
Fibrosis
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Cystic Fibrosis
Hypertension, Pulmonary
Pulmonary Fibrosis
Emphysema
Pulmonary Emphysema
Sarcoidosis
Bronchiectasis
Alpha 1-Antitrypsin Deficiency
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Bronchial Diseases
Liver Diseases
Subcutaneous Emphysema
Pharmaceutical Solutions


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