Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT04521569
Eligibility Criteria:
Inclusion Criteria:
Donor Lung Inclusion Criteria for EVLP
1. At the time of clinical evaluation, the PaO2/FiO2 ≤ 300mm Hg OR
2. If the PaO2/FiO2 is \> 300mm hg and the donor has any one of more of the following donor risk factors:
1. Multiple blood transfusions
2. Pulmonary Edema detected via CXR, Bronchoscopy or palpation of the lungs
3. Donation after cardiac death donors
4. High risk donor history (example: asphyxia, hanging, drowning)
Donor lung Inclusion Criteria for Transplant Suitability after EVLP
1. Delta PaO2 greater than 350 mmhg (measured with an FiO2 set at 1.0) at two consecutive time periods at 2, 3, or 4 hours of EVLP.
2. Stability or improvement of other lung function parameters during EVLP perfusion, such as PVR, compliance, or airway pressures.
3. Lungs clinically suitable for transplantation (e.g. without signs of significant contusions, edema, or secretion) in the opinion of the surgical investigator(s).
Participant Inclusion Criteria
1. Subjects must be undergoing a single or bilateral lung transplantation for end-stage lung disease and thus meet all criteria to be listed. Single lungs are only allowable when initially placed as bilaterally block on EVLP circuit.
2. Male or female subject, 18 -75 years of age.
3. Subject agrees to accept EVLP perfused lungs.
4. Subjects must sign a study specific informed consent prior to study entry.
Exclusion Criteria:
Donor Lung Exclusion Criteria for EVLP
1. Donor lung has significant pneumonia as defined by positive bacterial growth in blood culture (not related to other source of infection) or persistent purulent, un-clearable secretions on bronchoscopy OR as determined by the investigator.
2. Donor has aspirated gastric contents into the lung. Donor lung has significant mechanical lung injury or trauma.
3. Donor lung has active infections disease, such as HIV, Hepatitis B or C, HTLV or syphilis.
4. Donor lung must not be split and perfused as single lung on EVLP circuit.
Donor Lung Exclusion Criteria for Transplant Suitability after EVLP (All of the below must be negative)
1. Delta PaO2 less than 350 mmHg (measured with FiO2 set at 1.0) at two consecutive time periods at 2, 3 or 4 hours of ex Vivo perfusion.
2. \> 10% functional deterioration of other lung parameters during EVLP such as PVR, compliance or airway pressures.
Participant Exclusion Criteria
1. Subject requires preoperative extracorporeal membrane oxygenation (ECMO).
2. Subjects who are receiving or have received within 30 days any other investigational agents.
3. Subjects with Burkolderia cepacia.
4. Subjects who have had a previous lung transplant.
5. Subjects who have an uncontrolled concurrent illness including, but not limited to an ongoing or active infection, uncontrolled congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements per investigator discretion.
6. Pregnant or breastfeeding women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04521569
Study Brief:
Protocol Section:
NCT04521569