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Lung TransplantNCT01365429

Novel Lung Trial: Normothermic Ex Vivo Lung Perfusion (Evlp) As An Assessment Of Extended/Marginal Donor Lungs

A study testing XPS™ with Steen Solution™ in people with Lung Transplant, run by XVIVO Perfusion at 18 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Transplant
What is being tested?
XPS™ with Steen Solution™
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
252 participants
Where
18 sitesUnited States
Study dates
May 2011to Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Recipient Inclusion/Exclusion Criteria The recipient inclusion/exclusion criteria apply to patients enrolled in the control or EVLP treatment arms.

  1. Recipient Inclusion Criteria
  2. Requires single or bilateral lung transplant.
  3. Male or Female, 18 years of age or older.
  4. Subject or Subject's Representative provides a legally effective informed consent.
  5. Recipient exclusion Criteria
  6. A recipient is HIV positive.
  7. A recipient has active Hepatitis.
  8. Investigator believes that the recipient has infection that excludes them from transplant in the study.
  9. To receive multi-organ transplant.
  10. Is on hemodialysis or has chronic severe renal dysfunction. Severe renal dysfunction is defined as a glomerular filtration rate of 29 or less (mL/min/1.73m2).
  11. Is to have planned concurrent cardiac procedures.
  12. A recipient is a re-transplant. (A re-transplant is defined as a recipient having the removal and transplant of a previously transplanted lung. A recipient with a previously single lung transplant is eligible to enroll in the trial if it is for the other lung and within 6 months of previous transplant.)
  13. A recipient is on Nova Lung, ECMO, or on mechanical ventilation. (CPAP and BIPAP are not exclusionary)

Donor Inclusion/Exclusion Criteria for EVLP Assessment

  1. Donor Inclusion Criteria
  2. The Donor lung must meet the following criteria to proceed with EVLP:
  3. At the time of the clinical evaluation , the PaO2/FiO2 ≤ 300mmHg Or If PaO2/FiO2 > 30mmHg and the donor has any one or more of the following donor risk factors:
  • Multiple blood transfusions.
  • Pulmonary edema detected via CXR, bronchoscopy or palpation of lungs.
  • Donation after circulatory death donors.
  • Investigator evaluation of donor lung as "unsuitable" for standard criteria for lung transplant. List reason for "unsuitable" determination.
  1. Donor Exclusion Criteria
  2. Lung has significant pneumonia and/or persistent purulent secretions on bronchoscopy as determined by investigator.
  3. Donor has known significant aspiration of gastric contents within the lung.
  4. Donor lung has significant mechanical lung injury or trauma determined by chest x-ray, bronchoscopy, CT Scan or visual inspection.
  5. Donor lung has active infectious disease such as HIV, Hepatitis B or C, HTLV or Syphilis. Note: This information is not available at the start of EVLP. Therefore this criteria can be assessed during or post EVLP, but prior to transplant.

Donor Inclusion/Exclusion Criteria for Transplant Suitability after EVLP

  1. Donor Inclusion Criteria for Transplant Suitability
  2. Surgeon must be clinically satisfied with the lung evaluation (i.e.) overall improvement, if not, the reason for refusal must be listed.
  3. Stability or improvement of other lung function parameters during EVLP perfusion - PVR, Compliance, Airway Pressures.
  4. Two delta PO2 greater than 350 mmHg, if two delta PO2 mm Hg are not met than three out of four of the following parameters must be present:
  • One delta PO2 of > 350 or absolute PO2 of > 400.
  • Chest x-ray findings with absence or improvement of pulmonary edema/infiltrates
  • Compliance static (greater than 35 single and greater than 60 for a double)
  • Absence of consolidation by palpation
  1. Donor Exclusion Criteria for Transplant Suitability after EVLP
  2. All delta PO2 (s) are less than 350 mmHg (measured with a FiO2 set at 1.0) or all absolute PO2s are less than 400.
  3. Overall greater than 10-15% Functional deterioration of other lung function across all parameters (PVR, Compliance, PawP) with chest x-ray findings showing deterioration.
  4. Donor lung positive for infectious diseases such as HIV, Hepatitis B or C, or Syphilis.

Note: This information is not available until at the start of EVLP. Therefore this criteria can be assessed during or post EVLP, but prior to transplant.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • University of Colorado

    Aurora, Colorado, 80045

  • University of Maryland

    Baltimore, Maryland, 21201

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • University of Chicago

    Chicago, Illinois, 60631

  • Ohio State University

    Columbus, Ohio, 43210

  • University of Texas Southwestern

    Dallas, Texas, 75390

  • Henry Ford

    Detroit, Michigan, 48202

  • Duke University

    Durham, North Carolina, 27710

  • University of Florida-Gainesville

    Gainesville, Florida, 32610

  • Indiana University Health

    Indianapolis, Indiana, 46202

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Columbia University Medical Centre

    New York, New York, 10032

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15632

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Barnes Jewish Hospital

    St Louis, Missouri, 63110

  • Tampa General Hospital

    Tampa, Florida, 33606

Other trials in United States

About this study

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.

Read the detailed description

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.

Conditions
Lung Transplant
Being tested
XPS™ with Steen Solution™
Keywords
Lung Transplant, Transplantation Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XPS™ with Steen Solution™Device

    Also called EVLP, ex vivo lung perfusion

    The XPS™ System is an integrated cardiac bypass system comprised of various components such as a Maquet CardioHelp centrifugal pump (K102726), the HicoVariotherm Heater/Cooler, the Hamilton C2 ICU (intensive care unit) pressure- controlled ventilator (K092148), the perfusate gas monitors, and the display monitors. The XPS™ System is responsible for housing the organ for preservation, providing the normothermic environment, and perfusing the organ with the STEEN Solution™. Donor lungs that meet inclusion criteria are placed on the XPS™ and rewarmed and perfused with STEEN Solution™ and ventilated for 3-6 hours. If the lungs meet transplant suitability, they are cooled down and transplanted into a consented recipient that meet's trial criteria.

Study groups in NCT01365429
Study groupRoleWhat they receive
EVLP GroupExperimentalEVLP Group are those recipient lung transplant patients that received donor lungs that had been placed on the XPS™ with Steen Solution™ and undergone ex-vivo lung perfusion before being transplanted.
Receives: Device: XPS™ with Steen Solution™
Control GroupNo interventionControl Group are those recipient lung transplant patients that receive donor lungs via conventional transplant.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PAS Study Primary Endpoint

    The primary end point is a co-primary endpoint comparing survival rates and rates of grade 3 PGD at 72 hours with success if and only if both endpoints are met.

    Treatment Group (T) = EVLP transplant subjects Control Group (C) = standard transplant subjects

    Co-Primary Endpoints:

    Endpoint #1: Survival of T is non-inferior to C Ho: C - T ≥ M1 (T is inferior to the control by M1 or more) Ha: C - T < M1 (T is inferior to the control by less than M1) where M1 = 0.12 Endpoint #2: Rate of grade 3 PGD at 72 hours for T is non-inferior to the rate for C Ho: C - T ≥ M2 Ha: C - T < M2 where M2 = 0.12

    Measured: 3 Years

  2. PMA Study Primary Endpoint

    The primary end point is non-inferiority of the 3-year survival rate of the EVLP group as compared to 3-year survival rate of the control group.

    Ho: C - T ≥ M3 (T is inferior to the control by M3 or more) Ha: C - T < M3 (T is inferior to the control by less than M3) where M3 = 0.12

    Measured: 72hrs and Survival

Secondary outcomes (2)

  1. PMA Secondary Endpoints

    Primary Lung Graft Dysfunction (PGD) is an indicator for significant morbidity The PMA secondary endpoints are as follows:

    • FEV1 at 3 mos, 6 mos, 9 mos, and 1 yr
    • PGD score at 24 and 48 hrs
    • ICU LOS
    • Hospital LOS
    • Use of ECMO due to lung function post transplant
    • Duration of mechanical ventilation post transplant
    • Quality of Life and functional status at one year

    Measured: 3 Years

  2. PAS Secondary Endpoint:

    Quality of Life measured by functional status, physical capability, and employment limitations.

    • Episodes of rejection per UNOS registry
    • FEV1 at 1, 2, 3, 4, and 5 years

    Measured: 5 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionDec 2017
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01365429
Sponsor's protocol ID
VSS-NA-001, XVO-NA-002
Status last verified
Mar 2018
First submitted
2 Jun 2011
Last updated
7 Mar 2018
Results posted
No
Data monitoring committee
Yes

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. doi: 10.1067/mtc.2002.120345.

    PubMed 11882811

  • Fisher AJ, Donnelly SC, Hirani N, Haslett C, Strieter RM, Dark JH, Corris PA. Elevated levels of interleukin-8 in donor lungs is associated with early graft failure after lung transplantation. Am J Respir Crit Care Med. 2001 Jan;163(1):259-65. doi: 10.1164/ajrccm.163.1.2005093.

    PubMed 11208654

  • Power BM, Van Heerden PV. The physiological changes associated with brain death--current concepts and implications for treatment of the brain dead organ donor. Anaesth Intensive Care. 1995 Feb;23(1):26-36. doi: 10.1177/0310057X9502300107.

    PubMed 7778744

  • 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.

    PubMed 17227559

  • Botha P, Fisher AJ, Dark JH. Marginal lung donors: A diminishing margin of safety? Transplantation. 2006 Nov 27;82(10):1273-9. doi: 10.1097/01.tp.0000236099.52382.74.

    PubMed 17130774

  • 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.

    PubMed 15699761

  • 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.

    PubMed 16678604

  • Cohen RG, Starnes VA. Living donor lung transplantation. World J Surg. 2001 Feb;25(2):244-50. doi: 10.1007/s002680020025.

    PubMed 11338028

  • Yamane M, Date H, Okazaki M, Toyooka S, Aoe M, Sano Y. Long-term improvement in pulmonary function after living donor lobar lung transplantation. J Heart Lung Transplant. 2007 Jul;26(7):687-92. doi: 10.1016/j.healun.2007.04.008. Epub 2007 Jun 13.

    PubMed 17613398

  • 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.

    PubMed 11265950

  • de Antonio DG, Marcos R, Laporta R, Mora G, Garcia-Gallo C, Gamez P, Cordoba M, Moradiellos J, Ussetti P, Carreno MC, Nunez JR, Calatayud J, Del Rio F, Varela A. Results of clinical lung transplant from uncontrolled non-heart-beating donors. J Heart Lung Transplant. 2007 May;26(5):529-34. doi: 10.1016/j.healun.2007.01.028.

    PubMed 17449425

  • Steen S, Liao Q, Wierup PN, Bolys R, Pierre L, Sjoberg T. Transplantation of lungs from non-heart-beating donors after functional assessment ex vivo. Ann Thorac Surg. 2003 Jul;76(1):244-52; discussion 252. doi: 10.1016/s0003-4975(03)00191-7.

    PubMed 12842550

  • Snell GI, Oto T, Levvey B, McEgan R, Mennan M, Higuchi T, Eriksson L, Williams TJ, Rosenfeldt F. Evaluation of techniques for lung transplantation following donation after cardiac death. Ann Thorac Surg. 2006 Jun;81(6):2014-9. doi: 10.1016/j.athoracsur.2006.01.014.

    PubMed 16731122

  • 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.

    PubMed 19632569

  • 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.

    PubMed 18954650

Questions about this trial

What is this clinical trial studying?

A study testing XPS™ with Steen Solution™ in people with Lung Transplant, run by XVIVO Perfusion at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PAS Study Primary Endpoint (time frame: 3 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01365429, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.

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