Trial record 2 of 3 for:
Lung Ventilation/Perfusion Scan | Open Studies | NIH, U.S. Fed
Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability
This study is not yet open for participant recruitment.
Verified March 2013 by University of North Carolina, Chapel Hill
Sponsor:
University of North Carolina, Chapel Hill
Collaborators:
Duke University
Vitrolife
XVIVO Perfusion
Information provided by (Responsible Party):
Tom Egan, MD,MsC, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01615484
First received: June 6, 2012
Last updated: March 8, 2013
Last verified: March 2013
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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: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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:
MedlinePlus related topics:
Alpha-1 Antitrypsin Deficiency
COPD (Chronic Obstructive Pulmonary Disease)
Cystic Fibrosis
Emphysema
High Blood Pressure
Lung Transplantation
Pulmonary Fibrosis
Pulmonary Hypertension
Sarcoidosis
U.S. FDA Resources
Further study details as provided by University of North Carolina, Chapel Hill:
Primary Outcome Measures:
- 30 Day Mortality and Graft Survival [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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. ] [ 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.
- Bronchiolitis Obliterans Syndrome (BOS) free graft survival. [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]Bronchiolitis Obliterans Syndrome (BOS) free graft survival at 12 months is being used as a secondary outcome.
| Estimated Enrollment: | 10 |
| Study Start Date: | June 2013 |
| 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 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.
|
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01615484
Contacts
| Contact: Thomas M Egan, MD, MSc, FACS | 919-966-3381 | thomas_egan@med.unc.edu |
Locations
| United States, North Carolina | |
| UNC-Chapel Hill | Not yet recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Thomas M Egan, MD, MSc., FACS 919-966-3381 thomas_egan@med.unc.edu | |
| Principal Investigator: Thomas M. Egan, MD, MSc. | |
| Sub-Investigator: Peadar Noone, MD | |
| Sub-Investigator: Benjamin Haithcock, MD | |
| Sub-Investigator: Katherine Birchard, MD | |
| Sub-Investigator: William Funkhouser, MD, PhD | |
| Duke University Medical Center | Not yet recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Thomas M. Egan, MD, MSc., FACS 919-966-3381 thomas_egan@med.unc.edu | |
| Sub-Investigator: R. Duane Davis, MD | |
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Duke University
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: | NCT01615484 History of Changes |
| Other Study ID Numbers: | UNC-002 Vitrolife |
| Study First Received: | June 6, 2012 |
| Last Updated: | March 8, 2013 |
| 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:
|
Pulmonary Emphysema Hypertension, Pulmonary Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Pulmonary Fibrosis Lung Diseases, Obstructive Bronchiectasis Cystic Fibrosis Emphysema Fibrosis Hypertension Sarcoidosis Alpha 1-Antitrypsin Deficiency |
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 |
ClinicalTrials.gov processed this record on May 22, 2013