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

Primary Purpose

Emphysema, Chronic Obstructive Pulmonary Disease (COPD), Cystic Fibrosis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

STEEN Solution™

About this trial

This is an interventional treatment trial for Emphysema focused on measuring Lung Transplant, Emphysema, Chronic Obstructive Pulmonary Disease (COPD), Cystic Fibrosis, Pulmonary Fibrosis, Bronchiectasis, Sarcoidosis, Pulmonary Hypertension, Alpha-1 Antitrypsin Deficiency

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

UNC-Chapel Hill
Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ex-vivo lung perfusion (EVLP) with STEEN Solution™

Lung transplant from conventional brain-dead organ donor

Arm Description

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.

No experimental procedures will be carried out.

Outcomes

Primary Outcome Measures

30 Day Mortality and Graft Survival

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)

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 Outcome Measures

ICU Length of Stay

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.

Day 7 Ventilator/ECMO Status

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

Recipient Mortality at 12 Months

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

Bronchiolitis Obliterans Syndrome (BOS) Free Graft Survival

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

Full Information

NCT ID

NCT01615484

First Posted

June 6, 2012

Last Updated

May 9, 2018

Sponsor

University of North Carolina, Chapel Hill

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01615484

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of North Carolina, Chapel Hill

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Emphysema, Chronic Obstructive Pulmonary Disease (COPD), Cystic Fibrosis, Pulmonary Fibrosis, Bronchiectasis, Sarcoidosis, Pulmonary Hypertension, Alpha-1 Antitrypsin Deficiency

Keywords

Lung Transplant, Emphysema, Chronic Obstructive Pulmonary Disease (COPD), Cystic Fibrosis, Pulmonary Fibrosis, Bronchiectasis, Sarcoidosis, Pulmonary Hypertension, Alpha-1 Antitrypsin Deficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ex-vivo lung perfusion (EVLP) with STEEN Solution™

Arm Type

Experimental

Arm Description

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.

Arm Title

Lung transplant from conventional brain-dead organ donor

Arm Type

No Intervention

Arm Description

No experimental procedures will be carried out.

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

STEEN Solution™

Intervention Description

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 Outcome Measure Information:

Title

30 Day Mortality and Graft Survival

Description

Time Frame

30 Days

Title

Primary Lung Graft Dysfunction (PGD)

Description

Time Frame

24 and 72 hours

Secondary Outcome Measure Information:

Title

ICU Length of Stay

Description

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.

Time Frame

Time to Discharge, up to 30 days

Title

Day 7 Ventilator/ECMO Status

Description

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

Time Frame

7 Days Post Transplant.

Title

Recipient Mortality at 12 Months

Description

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

Time Frame

12 months

Title

Bronchiolitis Obliterans Syndrome (BOS) Free Graft Survival

Description

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

Time Frame

12 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas M. Egan, MD, MSc.

Organizational Affiliation

UNC-Chapel Hill

Official's Role

Principal Investigator

Facility Information:

Facility Name

UNC-Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

16818116

Citation

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Citation

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Citation

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Citation

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Citation

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Citation

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

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