Lung Transplantation
Conditions
Keywords
Lung, Transplantation, Lung Transplantation, Transplantation Lung
Brief summary
The use of ex vivo lung perfusion (EVLP) will allow for a secondary evaluation technique for donor lungs that fail to meet standard acceptability criteria. This advanced assessment might lead to increased utilization rates of donor lungs and improved outcomes after lung transplantation.
Detailed description
Human donor lungs that do not meet the standard clinical criteria for donor lung utilization but fit into the study inclusion criteria will be retrieved from the donor using current donor lung retrieval techniques. These lungs will be brought to the study transplant center to be re-assessed by the transplant team. The lungs will be physiologically assessed during ex vivo perfusion with Steen Solution. Perfusion of these lungs will be performed using Steen solution with the addition of methylprednisolone, heparin and antibiotics. With respect to the decision of lung utilization those organs with a delta pO2 (Δ pO2 = Pulmonary vein pO2 - pulmonary artery pO2) during ex vivo perfusion assessment \> 350mmHg, good lung compliance, and a favorable opinion of the transplant surgeon will be considered transplantable. Lungs will be excluded for transplantation: if the Δ pO2 is less than 350mmHg or if they demonstrate \>10% deterioration in any of the following functional parameters: pulmonary vascular resistance (PVR), dynamic compliance or airway pressures. Lungs will also be excluded if they are deemed unsuitable based on the clinical judgment of the lung transplant surgeon.
Interventions
DRUGEx vivo lung perfusion with Steen Solution™
The circuit is primed with 2,000cc Steen Solution™. At one hour of EVLP, 500 cc of circulated perfusate was removed and replenished with 500 cc of fresh perfusate. After that, 250 cc of perfusate was exchanged every hour.
Sponsors
XVIVO Perfusion
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for donor lung: 1. Recipient to undergo a single or bilateral Lung Transplantation 2. Last donor PaO2/FiO2 ≤ 300mmHg 3. Poor oxygenation and/or poor lung compliance is the primary reason for unsuitability 4. Absence of pneumonia, persistent purulent secretion on bronchoscopy or significant mechanical trauma
Exclusion criteria
1. Infection 2. Aspiration 3. Significant mechanical lung injury - contusion 4. Infectious diseases : HIV, Hepatitis B and C, HTLV & Syphilis 5. Malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PGD scores in the first 72 hours after lung transplantation. | 72 hours | Immediate lung function is one of the key factors in determining the impact of donor lung quality, therefore the PGD score within 72 hrs was selected as the primary endpoint. |
| 30 day Mortality | 30 days | Mortality at 30 days post transplant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator duration | 30 days | How long was the patient on the ventilator after lung transplantation and was there an increased time on ventilator for the patient after EVLP. |
| Extra-corporeal membrane oxygenation use | 30 days | If the patient needed to be placed on extra-corporeal membrane oxygenation after transplantation. |
| Hospital length of stay | 30 days | Time in the hospital |
| Intensive Care Unit length of stay | 30 days | — |
| Bronchial complications | 30 days | To see if there was an increased risk for bronchial complications |
Countries
Canada
Outcome results
None listed