Skip to main content
OpenTrials
Completed

NCT Number: NCT01615484

Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Emphysema Alpha-1 Antitrypsin Deficiency Bronchial Diseases Bronchiectasis Cardiovascular Diseases Chronic Disease Chronic Obstructive Pulmonary Disease (COPD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Disease Attributes Fibrosis Genetic Diseases, Inborn Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Hypertension Hypertension, Pulmonary Immune System Diseases Infant, Newborn, Diseases Liver Diseases Lung Diseases Lung Diseases, Interstitial Lung Diseases, Obstructive Lymphatic Diseases Lymphoproliferative Disorders Pancreatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Pulmonary Fibrosis Pulmonary Hypertension Respiratory Tract Diseases Sarcoidosis Subcutaneous Emphysema Vascular Diseases alpha 1-Antitrypsin Deficiency

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC-Chapel Hill, Chapel Hill, North Carolina, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™

Procedure

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.

STEEN Solution™

Device

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.

Primary outcomes

  1. 30 Day Mortality and Graft Survival

    Time frame: 30 Days

    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.

  2. Primary Lung Graft Dysfunction (PGD)

    Time frame: 24 and 72 hours

    Primary Lung Graft Dysfunction (PGD) is an indicator for significant morbidity and mortality after lung transplantation.

    Grade 0: PaO2/FIO2 > 300 with normal chest radiograph; Grade 1: PaO2/FIO2 > 300 with diffuse infiltrates on the chest radiograph; Grade 2: PaO2/FIO2 between 200 and 300; Grade 3: PaO2/FIO2 < 200.

Secondary outcomes

  1. ICU Length of Stay

    Time frame: Time to Discharge, up to 30 days

    The length of ICU stay in days is another standard research and clinical outcome assessment post transplant and has been selected as a secondary objective.

  2. Day 7 Ventilator/ECMO Status

    Time frame: 7 Days Post Transplant.

    Participants' status at Day 7 defined as the following: mechanical ventilation, extra-corporeal membrane oxygenator (ECMO), or extubated.

  3. Recipient Mortality at 12 Months

    Time frame: 12 months

    Recipient mortality at 12 months post transplant is being evaluated as a secondary objective.

  4. Bronchiolitis Obliterans Syndrome (BOS) Free Graft Survival

    Time frame: 12 Months

    Bronchiolitis Obliterans Syndrome (BOS) free graft survival at 12 months is being used as a secondary outcome.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Duke University
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Vitrolife
  • XVIVO Perfusion

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jun 8, 2012
Registry last updated
Jun 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.