Lung transplantation
Conditions
Interventions
experimental group:ex-vivo lung perfusion
control group:None
Sponsors
Shanghai Pulmonary Hospital, Tongji University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Recipient Inclusion Criteria 1) Male or female patient requiring single or bilateral lung transplant; 2) 18 years of age or older; 3) Can provide informed consent. 2. Pre-EVLP Donor Inclusion Criteria 1) PaO2/FiO2 lower or equal 300 mmHg; 2) Or PaO2/FiO2 > 300 mmHg and one or more of the following: Multiple blood transfusions (more or equal to 10 units)Pulmonary edemaDonation after circulatory deathDeemed unsuitable by PI (this must be documented in source document); 3. Post-EVLP Inclusion Criteria 1) Surgeon clinically satisfied; 2) Stability or improvement in PVR, compliance, and airway pressures; 3) Two delta PO2 more or equal 350 mmHg (do not have to be consecutive); 4) Or at least three of the followingOne delta PO2 more or equal 350 or absolute PO2 more or equal 400Chest x-ray finding with absence or improvement of edema/infiltratesCompliance-static (> 35 single, > 60 double);no consolidation on palpation.
Exclusion criteria
Exclusion criteria: 1. Pre-EVLP Donor Exclusion Criteria 1) Significant active pneumonia and/or purulent secretions on bronchoscopy or as determined by investigator; 2) Significant aspiration of gastric contents within the lung; 3) Significant mechanical lung injury or trauma determined by chest x-ray, bronchoscopy, CT scan or visual inspection; 4) Active infectious disease (HIV, Hep B, Hep C, Syphilis). 2. Post-EVLP Exclusion Criteria 1) All delta PO2 s 10-15% functional deterioration of other lung functions with chest x-ray showing deterioration; 4) Positive for infectious disease (HIV, Hep B, Hep C, Syphilis and other infections).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One-year mortality after lung transplantation;Primary graft dysfunction (PGD) occurs within the first 72 hours;30 days mortality after lung transplantation; | — |
Secondary
| Measure | Time frame |
|---|---|
| IL-1ß;IL-6;IL-12;TNF-a;CXCL1;MIP1a;MIP1ß;RANTES;IFN-?;IL-10;IL-4;IL-8;IL-23;MCP-1;IP-10;FEV1 in the first 3 months, 6 months, and 1 year after lung transplantation;Primary graft dysfunction (PGD) occurs within the first 24 and 48 hours;Complications after lung transplantation;Length of stay in ICU;Length of stay;Duration of ECMO after lung transplantation;Ventilation time after lung transplantation;Quality of life in the first 1 year after lung transplantation; | — |
Countries
China
Contacts
Public ContactYu-ping LI
Shanghai Pulmonary Hospital
Outcome results
None listed