Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01967953
Recruitment Status : Completed
First Posted : October 23, 2013
Last Update Posted : October 23, 2013
Sponsor:
Information provided by (Responsible Party):
Franco Valenza, MD, Policlinico Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Disorder Related to Lung Transplantation Brain Death Graft Failure Primary Graft Dysfunction Procedure: EVLP Group Phase 1

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Ex-Vivo Lung Perfusion to Improve Donor Lung Function and Increase the Number of Organs Available for Transplantation
Study Start Date : January 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard Group

Recipients of lungs procured from brain death donors deemed suitable for transplantation according to standard criteria.

Events: lung procurement, cold storage on ice, transplantation.

Experimental: EVLP Group

Recipients of marginal lungs procured from brain death donors and reconditioned with ex-vivo lung perfusion (EVLP).

Events: lung procurement, cold storage on ice, reconditioning by EVLP, cold storage on ice, transplantation.

Procedure: EVLP Group

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 Outcome Measures :
  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 Outcome Measures :
  1. Duration of mechanical ventilation after transplantation [ Time Frame: 30 days ]
  2. ICU length of stay after transplantation [ Time Frame: 30 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria for donor lung:

  1. Recipient to undergo single or bilateral Lung Transplantation
  2. 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:

  1. Massive lung contusion
  2. Aspiration
  3. Pneumonia
  4. Sepsis
  5. Malignancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967953


Locations
Layout table for location information
Italy
Fondazione Ca' Granda IRCCS Ospedale Maggiore Policlinico
Milan, Italy, 20122
Sponsors and Collaborators
Policlinico Hospital
Investigators
Layout table for investigator information
Principal Investigator: Franco Valenza, MD Fondazione Ca' Granda IRCCS Ospedale Maggiore Policlinico Milan Italy

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Franco Valenza, MD, Assistant Professor Anaesthesia and Intensive Care, Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Policlinico Hospital
ClinicalTrials.gov Identifier: NCT01967953     History of Changes
Other Study ID Numbers: EVLP_2011
First Posted: October 23, 2013    Key Record Dates
Last Update Posted: October 23, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Death
Primary Graft Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Death
Pathologic Processes
Reperfusion Injury
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications