Normothermic Ex Vivo Lung Perfusion (EVLP) For An Improved Assessment of Donor Lungs For Transplantation (HELP)
|Lung Transplantation||Drug: Ex vivo lung perfusion with Steen Solution™||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Normothermic Ex Vivo Lung Perfusion (EVLP) For An Improved Assessment of Donor Lungs For Transplantation|
- PGD scores in the first 72 hours after lung transplantation. [ Time Frame: 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 [ Time Frame: 30 days ]Mortality at 30 days post transplant
- Extra-corporeal membrane oxygenation use [ Time Frame: 30 days ]If the patient needed to be placed on extra-corporeal membrane oxygenation after transplantation.
- Bronchial complications [ Time Frame: 30 days ]To see if there was an increased risk for bronchial complications
- Ventilator duration [ Time Frame: 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.
- Intensive Care Unit length of stay [ Time Frame: 30 days ]
- Hospital length of stay [ Time Frame: 30 days ]Time in the hospital
|Study Start Date:||August 2008|
|Study Completion Date:||February 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Experimental: EVLP Group
EVLP Group are those recipient lung transplant patients that received donor lungs that had been placed on the ex vivo lung perfusion system with Steen Solution™ .
Drug: Ex 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01190059
|Toronto General Hospital|
|Toronto, Ontario, Canada, M5G 1Z5|
|Principal Investigator:||Shaf Keshavjee, MD,MSc,FRCSC||University of Toronto-Toronto General Hospital|