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Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability

Primary Purpose

Emphysema, Chronic Obstructive Pulmonary Disease (COPD), Cystic Fibrosis

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Steen Solution™

Conventional Lung Transplant

About this trial

This is an interventional device feasibility trial for Emphysema focused on measuring Lung Transplant, Emphysema, Chronic Obstructive Pulmonary Disease (COPD), Cystic Fibrosis, Pulmonary Fibrosis, Bronchiectasis, Sarcoidosis, Pulmonary Hypertension, Alpha-1 Antitrypsin Deficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Lung Recipient 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 lung transplant at UNC.
Male or Female, 18 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.

Lung Recipient Exclusion Criteria:

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

Sites / Locations

UNC Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EVLP with STEEN Solution™

Conventional Lung transplant

Arm Description

The perfusion of the lungs will be performed using STEEN Solution™ and then physiologically assessed. Lungs deemed suitable will be transplanted after Ex-vivo Perfusion w/ STEEN Solution™.

No experimental procedures will be carried out. Lungs from conventional brain-dead organ donors will be used for transplant.

Outcomes

Primary Outcome Measures

30 Day Mortality

The primary objective evaluated for this study is recipient mortality at 30 days post transplant. 30 day mortality is used as a standard research assessment to evaluate post transplant outcomes.

Secondary Outcome Measures

Primary Lung Graft Dysfunction (PGD)

Primary Lung Graft Dysfunction (PGD) is an indicator for significant morbidity and mortality after lung transplantation. Grade 0: PaO2*/FIO2** > 300 with normal chest radiograph; Grade 1: PaO2/FIO2 > 300 with diffuse infiltrates on the chest radiograph; Grade 2: PaO2/FIO2 between 200 and 300; Grade 3: PaO2/FIO2 < 200. * partial pressure of oxygen in the arterial blood (PaO2) ** fraction of inspired oxygen inspired oxygen fraction (FIO2)

ICU Length of Stay

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

7 days ventilator or extra-corporeal membrane oxygenator (ECMO free are being evaluated as secondary objectives.

Recipient mortality at 12 months.

Recipient mortality at 12 months post transplant is being evaluated as a secondary objective.

Full Information

NCT ID

NCT01241942

First Posted

November 12, 2010

Last Updated

July 11, 2018

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Vitrolife, XVIVO Perfusion

1. Study Identification

Unique Protocol Identification Number

NCT01241942

Brief Title

Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability

Official Title

Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Terminated

Why Stopped

Funding exhausted.

Study Start Date

December 2010 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of North Carolina, Chapel Hill

Collaborators

Vitrolife, XVIVO Perfusion

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this research study is to perfect the technique of EVLP and learn about the safety of transplanting lungs 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 lung perfusion and ventilation (EVLP) is to learn how well the lungs work, and whether they are likely safe to transplant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Emphysema, Chronic Obstructive Pulmonary Disease (COPD), Cystic Fibrosis, Pulmonary Fibrosis, Bronchiectasis, Sarcoidosis, Pulmonary Hypertension, Alpha-1 Antitrypsin Deficiency

Keywords

Lung Transplant, Emphysema, Chronic Obstructive Pulmonary Disease (COPD), Cystic Fibrosis, Pulmonary Fibrosis, Bronchiectasis, Sarcoidosis, Pulmonary Hypertension, Alpha-1 Antitrypsin Deficiency

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EVLP with STEEN Solution™

Arm Type

Experimental

Arm Description

The perfusion of the lungs will be performed using STEEN Solution™ and then physiologically assessed. Lungs deemed suitable will be transplanted after Ex-vivo Perfusion w/ STEEN Solution™.

Arm Title

Conventional Lung transplant

Arm Type

Active Comparator

Arm Description

No experimental procedures will be carried out. Lungs from conventional brain-dead organ donors will be used for transplant.

Intervention Type

Device

Intervention Name(s)

Steen Solution™

Intervention Description

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. After EVLP, lungs will be cooled in the circuit to room temperature, then flushed with cold Perfadex™ and taken to UNC Hospitals (UNCH) where they will have an ex-vivo CT scan. Lungs determined suitable will be offered to consented patients at UNCH 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 with Steen Solution™ will be transplanted into recipients as per current clinical practice.

Intervention Type

Other

Intervention Name(s)

Conventional Lung Transplant

Intervention Description

No experimental procedures will be carried out. Lungs from conventional brain-dead organ donors will be used for transplant.

Primary Outcome Measure Information:

Title

30 Day Mortality

Description

The primary objective evaluated for this study is recipient mortality at 30 days post transplant. 30 day mortality is used as a standard research assessment to evaluate post transplant outcomes.

Time Frame

30 Days

Secondary Outcome Measure Information:

Title

Primary Lung Graft Dysfunction (PGD)

Description

Time Frame

24 and 72 hours post transplant.

Title

ICU Length of Stay

Description

The length of ICU stay is another standard research and clinical outcome assessment post transplant and has been selected as a secondary objective.

Time Frame

Time to Discharge.

Title

Day 7 Ventilator/ECMO Status

Description

7 days ventilator or extra-corporeal membrane oxygenator (ECMO free are being evaluated as secondary objectives.

Time Frame

7 Days Post Transplant.

Title

Recipient mortality at 12 months.

Description

Recipient mortality at 12 months post transplant is being evaluated as a secondary objective.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Lung Recipient 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 lung transplant at UNC. Male or Female, 18 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. Lung Recipient Exclusion Criteria: Recipient fails to meet standard of care requirements for lung transplant, or decides not to participate.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas M. Egan, MD, MSc.

Organizational Affiliation

UNC-Chapel Hill

Official's Role

Principal Investigator

Facility Information:

Facility Name

UNC Hospitals

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

16818116

Citation

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. doi: 10.1016/j.healun.2006.03.011. No abstract available.

Results Reference

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PubMed Identifier

19101308

Citation

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.

Results Reference

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PubMed Identifier

18954650

Citation

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.

Results Reference

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PubMed Identifier

19059112

Citation

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.

Results Reference

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PubMed Identifier

16564244

Citation

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. doi: 10.1016/j.athoracsur.2005.09.034.

Results Reference

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PubMed Identifier

16210116

Citation

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.

Results Reference

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PubMed Identifier

18852649

Citation

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.

Results Reference

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PubMed Identifier

19118301

Citation

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.

Results Reference

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PubMed Identifier

20368171

Citation

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.

Results Reference

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Links:

URL

https://optn.transplant.hrsa.gov/

Description

Organ Procurement and Transplantation Network web site (National Data/ Waiting List Removals/ Lung/ Removal Reasons by Year)

Learn more about this trial

Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability

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