Status:
COMPLETED
The University of Alberta Negative Pressure Ventilation Ex-Vivo Lung Perfusion (NPV-EVLP) Trial
Lead Sponsor:
University of Alberta
Conditions:
Ex-Vivo Lung Transplantation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This project is focused on helping one of the most vulnerable patient populations in medicine, patients with end-stage chronic lung disease. Lung transplantation is the only cure for end-stage lung di...
Eligibility Criteria
Inclusion
- 2 PRE-NPV-EVLP Donor Eligibility Criteria
- 2.1 Donor MUST meet ANY ONE of the following Inclusion Criteria to proceed with NPV-EVLP:
- Best ratio of the PaO2 to FiO2 of \< 300mmHg;
- Pulmonary edema, defined as bilateral interstitial infiltrates without evidence of infection, detected on the last chest radiograph by the lung-transplantation physician assessing the donor;
- Poor lung deflation or inflation during direct intraoperative visual examination at the donor site;
- Donor age is ≥ 55 years;
- Expected cold ischemic time \> 6 hours;
- Blood transfusions ≥ 10 units; or
- Donation after cardiac death (DCD), as defined by Maastricht category III (donor without a heartbeat and with cardiocirculatory death imminent after withdrawal of treatment) or category IV (cardiocirculatory death in a brain-dead donor).
- 2.2 Donor Exclusion Criteria to NOT proceed with NPV-EVLP:
- Donor lungs with established pneumonia;
- Severe mechanical lung injury (i.e., contusions in more than one lobe) or trauma determined by chest x-ray, bronchoscopy, CT scan or visual inspection; or
- Gross gastric aspiration within the lungs
- Donor lungs have active infectious disease such as HIV, Hepatitis B, Hepatitis C, West Nile Virus (WNV), HTLV, or Syphillis (if this information not available at start of EVLP, it should be re-assessed prior to transplant).
- 3 POST-NPV-EVLP Donor Eligibility Criteria
- 3.1 Donor Inclusion Criteria to proceed with Transplant:
- Surgeon must be satisfied with the clinical evaluation and appearance of the lungs; if not, reason for refusal must be documented;
- Lungs show PaO2/FiO2 ratio ≥ 350mmHg; AND
- Deterioration of less than 15% from baseline for physiological measurements pulmonary vascular resistance (PVR), dynamic compliance and peak inspiratory pressure.
- 3.2 Donor Exclusion Criteria to proceed with Transplant:
- Lungs show a PaO2/FiO2 ratio of \< 350mmHg;
- Greater than 15% functional deterioration across the following physiological parameters: PVR, dynamic compliance and peak inspiratory pressure;
- Donor lungs are positive for infectious disease such as HIV, Hepatitis B, Hepatitis C, West Nile Virus (WNV),HTLV, or Syphillis.
- 4 Recipient Eligibility Criteria
- 4.1 Recipient Inclusion Criteria
- Patients on our institution's waitlist requiring bilateral transplantation
- Male or Female 18 years of age or older
- Written informed consent provided.
- 4.2Recipient Exclusion Criteria
- Multi-organ recipient or re-transplant
- HIV, Hepatitis, or other infection that excludes subject from transplant in the study
- Subject is on hemodialysis or has chronic severe renal dysfunction
- Concurrent cardiac procedure
- Recipient is on Nova Lung, ECMO or on mechanical ventilation (CPAP and BiPAP not exclusionary)
Exclusion
Key Trial Info
Start Date :
October 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03293043
Start Date
October 11 2018
End Date
April 22 2021
Last Update
April 26 2021
Active Locations (1)
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1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7