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

XVIVO

Status and phase: Completed; Phase 1

Conditions: Lung Transplantation

Treatments: Drug: Ex vivo lung perfusion with Steen Solution™

Study type: Interventional

Funder types: Industry

Identifiers

NCT01190059

139150 (Other Identifier)

VIT-001-TOR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

EVLP Group

Experimental group

Description:

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™ .

Treatment:

Drug: Ex vivo lung perfusion with Steen Solution™