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
  Purpose

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.


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 After Ex-vivo Perfusion w/ STEEN Solution™
Device: Steen Solution™
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Study Start Date: December 2010
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2016 (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 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.
No Intervention: Lung transplant from conventional brain-dead organ donor
No experimental procedures will be carried out.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241942

Locations
United States, North Carolina
UNC Hospitals
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Vitrolife
XVIVO Perfusion
Investigators
Principal Investigator: Thomas M. Egan, MD, MSc. UNC-Chapel Hill
  More Information

Additional Information:
Publications:

Responsible Party: Tom Egan, MD,MsC, Professor of Surgery, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01241942     History of Changes
Other Study ID Numbers: UNC-001 Vitrolife
Study First Received: November 12, 2010
Last Updated: May 2, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by 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:
Bronchiectasis
Cystic Fibrosis
Emphysema
Pulmonary Emphysema
Fibrosis
Hypertension
Hypertension, Pulmonary
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Pulmonary Fibrosis
Sarcoidosis
Alpha 1-Antitrypsin Deficiency
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Pancreatic Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Liver Diseases
Subcutaneous Emphysema
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014