Normothermic Ex Vivo Lung Perfusion (EVLP) For An Improved Assessment of Donor Lungs For Transplantation

Phase 1

Completed

• Conditions: Lung Transplantation
• Interventions: Drug: Ex vivo lung perfusion with Steen Solution™

• Registration Number: NCT01190059
• Lead Sponsor: XVIVO Perfusion

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.

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Study First Submitted: 2010-08-25
• Study First Submitted QC: 2010-08-25
• Study First Posted: 2010-08-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

1. Infection
2. Aspiration
3. Significant mechanical lung injury - contusion
4. Infectious diseases : HIV, Hepatitis B and C, HTLV & Syphilis
5. Malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EVLP Group	Ex vivo lung perfusion with Steen Solution™	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™ .

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Extra-corporeal membrane oxygenation use	30 days	If the patient needed to be placed on extra-corporeal membrane oxygenation after transplantation.
Bronchial complications	30 days	To see if there was an increased risk for bronchial complications
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.
Intensive Care Unit length of stay	30 days
Hospital length of stay	30 days	Time in the hospital

Trial Locations

Locations (1)

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada