Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01241942 |
|
Recruitment Status :
Terminated
(Funding exhausted.)
First Posted : November 16, 2010
Last Update Posted : February 6, 2017
|
Sponsor:
University of North Carolina, Chapel Hill
Collaborators:
Vitrolife
XVIVO Perfusion
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Emphysema Chronic Obstructive Pulmonary Disease (COPD) Cystic Fibrosis Pulmonary Fibrosis Bronchiectasis Sarcoidosis Pulmonary Hypertension Alpha-1 Antitrypsin Deficiency | Device: Steen Solution™ Other: Conventional Lung Transplant | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 103 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Device Feasibility |
| Official Title: | Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability |
| Study Start Date : | December 2010 |
| Actual Primary Completion Date : | December 2012 |
| Actual Study Completion Date : | June 2013 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
Experimental: EVLP with STEEN Solution™
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™.
|
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. 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 with Steen Solution™ will be transplanted into recipients as per current clinical practice. |
|
Active Comparator: Conventional Lung transplant
No experimental procedures will be carried out. Lungs from conventional brain-dead organ donors will be used for transplant.
|
Other: Conventional Lung Transplant
No experimental procedures will be carried out. Lungs from conventional brain-dead organ donors will be used for transplant. |
Primary Outcome Measures :
- 30 Day Mortality [ Time Frame: 30 Days ]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. ]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. ]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. ]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 ]Recipient mortality at 12 months post transplant is being evaluated as a secondary objective.
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Publications:
| Responsible Party: | University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT01241942 History of Changes |
| Other Study ID Numbers: |
UNC-001 Vitrolife |
| First Posted: | November 16, 2010 Key Record Dates |
| Last Update Posted: | February 6, 2017 |
| Last Verified: | July 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | Yes | |
| Device Product Not Approved or Cleared by U.S. FDA: | No | |
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:
|
Hypertension Lung Diseases Fibrosis Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Cystic Fibrosis Hypertension, Pulmonary Pulmonary Fibrosis Emphysema Pulmonary Emphysema Sarcoidosis Bronchiectasis Alpha 1-Antitrypsin Deficiency Vascular Diseases |
Cardiovascular Diseases Respiratory Tract Diseases Pathologic Processes Pancreatic Diseases Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lymphoproliferative Disorders Lymphatic Diseases Bronchial Diseases Liver Diseases Subcutaneous Emphysema Pharmaceutical Solutions |