Novel Lung Trial: Normothermic Ex Vivo Lung Perfusion (Evlp) As An Assessment Of Extended/Marginal Donor Lungs

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01365429
• Date of registration: 02/06/2011
• Primary sponsor: XVIVO Perfusion
• Public title: Novel Lung Trial: Normothermic Ex Vivo Lung Perfusion (Evlp) As An Assessment Of Extended/Marginal Donor Lungs
• Scientific title: Novel Lung Trial: Normothermic Ex Vivo Lung Perfusion (Evlp) As An Assessment Of Extended/Marginal Donor Lungs
• Date of first enrolment: May 2011
• Target sample size: 84
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01365429
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Countries of recruitment

United States

Key inclusion & exclusion criteria

Recipient Inclusion/Exclusion Criteria The recipient inclusion/exclusion criteria apply to
patients enrolled in the control or EVLP treatment arms.

1. Recipient Inclusion Criteria

1. Requires single or bilateral lung transplant.

2. Male or Female, 18 years of age or older.

3. Subject or Subject's Representative provides a legally effective informed
consent.

2. Recipient exclusion Criteria

1. A recipient is HIV positive.

2. A recipient has active Hepatitis.

3. A recipient has Burkholderia cepacia.

4. A recipient is a re-transplant. A re-transplant is defined as a recipient having
removal of a previously transplanted lung. A recipient with a previously singled
transplant is eligible to enroll in the trial if it is the other lung.

5. A recipient is on Nova Lung, ECMO, or on mechanical ventilation.

Donor Inclusion/Exclusion Criteria for EVLP Assessment

1. Donor Inclusion Criteria

1. The Donor lung must meet the following criteria to proceed with EVLP:

2. At the time of the clinical evaluation , the PaO2/FiO2 = 300mmHg Or If PaO2/FiO2
> 30mmHg and the donor has any one or more of the following donor risk factors:

- Multiple blood transfusions.

- Pulmonary edema detected via CXR, bronchoscopy or palpation of lungs.

- Donation after cardiac death donors.

- Investigator evaluation of donor lung as "unsuitable" for standard criteria
for lung transplant. List reason for "unsuitable" determination.

2. Donor Exclusion Criteria

1. lung has significant pneumonia and/or persistent purulent secretions on
bronchoscopy as determined by investigator.

2. Donor has aspirated gastric contents in to the lung. Donor lung has significant
mechanical lung injury or trauma.

3. Donor lung has active infectious disease such as HIV, Hepatitis B or C, HTLV or
Syphilis.

Donor Inclusion/Exclusion Criteria for Transplant Suitability after EVLP

1. Donor Inclusion Criteria for Transplant Suitability

1. ? PaO2 greater than 350 mmHg (measured with an FiO2 set at 1.0) at two
consecutive time periods at 2h, 3h or 4h of ex vivo perfusion.

2. Stability or improvement of other lung function parameters during EVLP perfusion
-PVR, Compliance, Airway Pressures.

3. Surgeon clinically satisfied with lung evaluation. If not provide a reason.

2. Donor Exclusion Criteria for Transplant Suitability after EVLP

1. ? PaO2 less than 350 mmHg (measured with an FiO2 set at 1.0) at two consecutive
time periods at 2h, 3h , or 4h of ex vivo perfusion

2. >10% Functional deterioration of other lung function parameters (PVR,
Compliance, PawP).



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Transplantation, Lungs

Intervention(s)

Drug: Ex vivo lung perfusion with Steen Solution™

Primary Outcome(s)

30 Day Mortality [Time Frame: 30 Days]

Secondary Outcome(s)

12 Month Survival [Time Frame: 12 Months]

Day 7 Ventilator/ECMO Status [Time Frame: 7 Days]

Intensive Care Unit Stay [Time Frame: 30 Days]

PGD Scores at 0,24,and 72 hours [Time Frame: 72 hours]

Secondary ID(s)

VSS-NA-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors