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NCT Number: NCT01967953

Ex-Vivo Lung Perfusion to Increase the Number of Organs for Transplantation

The recent introduction of ex-vivo lung perfusion (EVLP) as a tool to evaluate and recondition lungs from marginal donors has opened a new era in the field of lung transplantation.

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Key information

Conditions

Disorder Related to Lung Transplantation Brain Death Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Coma Consciousness Disorders Death Graft Failure Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Primary Graft Dysfunction Reperfusion Injury Unconsciousness Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fondazione Ca' Granda IRCCS Ospedale Maggiore Policlinico

Milan, Italy, 20122

About this study

Aim of the investigation: to compare the clinical outcome after transplantation of subjects receiving marginal lungs procured from brain death donors and reconditioned by EVLP, with that of subjects receiving lungs procured from standard donors.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for donor lung:

  • Recipient to undergo single or bilateral Lung Transplantation
  • Donor arterial partial pressure of oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) below 300 mmHg, or doubtful donor lung function

Exclusion criteria

for donor lung:

  • Massive lung contusion
  • Aspiration
  • Pneumonia
  • Sepsis
  • Malignancy

Treatment and study plan

EVLP Group

Procedure

EVLP technique: Steen solution; normothermia; low flow, open atrium, low hematocrit.

Endpoints of EVLP assessment of lungs suitability: oxygenation, respiratory mechanics, pulmonary vascular resistance, chest X-ray, fibrobronchoscopy

Primary outcomes

  1. Primary Graft Dysfunction 72 hours after lung transplantation (PGD72)

    Time frame: 72 hours

    Primary Graft Dysfunction 72 hours after transplantation (PGD72) definition: grade 3 according to the International Society of Heart and Lung Transplantation classification

  2. 30 day Mortality

    Time frame: 30 days

Secondary outcomes

  1. Duration of mechanical ventilation after transplantation

    Time frame: 30 days

  2. ICU length of stay after transplantation

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Policlinico Hospital

Other

Registry information

Official study title

Ex-Vivo Lung Perfusion to Improve Donor Lung Function and Increase the Number of Organs Available for Transplantation

Acronym: EVLP_MI

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 23, 2013
Registry last updated
Oct 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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