Lung transplantation
Conditions
Interventions
EVLP group:normothermic ex-vivo lung perfusion
Control group:Nil
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) Aged 18 years or older; 3) be able to 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) 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 following: One delta PO2 more or equal 350 or absolute PO2 more or equal 400; Chest x-ray finding with absence or improvement of edema/infiltrates; Compliance-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 |
|---|---|
| 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;Overall survival;The security of intervention;Quality of Life;Transplant complications; | — |
Secondary
| Measure | Time frame |
|---|---|
| LOS(length of stay); | — |
Countries
China
Contacts
Public ContactWen-xin HE
Shanghai Pulmonary Hospital, Tongji University School of Medicine
Outcome results
None listed