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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Vitrolife
XVIVO Perfusion
Information provided by (Responsible Party):
Tom Egan, MD,MsC, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01241942
First received: November 12, 2010
Last updated: May 2, 2014
Last verified: May 2014

November 12, 2010
May 2, 2014
December 2010
July 2016   (final data collection date for primary outcome measure)
30 Day Mortality [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01241942 on ClinicalTrials.gov Archive Site
  • Primary Lung Graft Dysfunction (PGD) [ Time Frame: 24 and 72 hours post transplant. ] [ Designated as safety issue: Yes ]
    Primary Lung Graft Dysfunction (PGD) is an indicator for significant morbidity and mortality after lung transplantation. PGD at 24 and 72 hours post LTX are secondary objectives.
  • ICU Length of Stay [ Time Frame: Time to Discharge. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Recipient mortality at 12 months post transplant is being evaluated as a secondary objective.
Same as current
Not Provided
Not Provided
 
Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability
Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability

The purpose of this research study is to 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 perfusion and ventilation is to learn how well the lungs work, and whether they are likely safe to transplant.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Emphysema
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Cystic Fibrosis
  • Pulmonary Fibrosis
  • Bronchiectasis
  • Sarcoidosis
  • Pulmonary Hypertension
  • Alpha-1 Antitrypsin Deficiency
  • Procedure: Transplantation of Lungs 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 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.
  • 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.
    Interventions:
    • Procedure: Transplantation of Lungs After Ex-vivo Perfusion w/ STEEN Solution™
    • Device: Steen Solution™
  • No Intervention: Lung transplant from conventional brain-dead organ donor
    No experimental procedures will be carried out.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
July 2017
July 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01241942
UNC-001 Vitrolife
Yes
Tom Egan, MD,MsC, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
  • Vitrolife
  • XVIVO Perfusion
Principal Investigator: Thomas M. Egan, MD, MSc. UNC-Chapel Hill
University of North Carolina, Chapel Hill
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP