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Trial record 3 of 20 for:    evlp

EVLP to Evaluate the Eligibility for Transplantation of DCD-Lungs (EVLP-DCD)

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ClinicalTrials.gov Identifier: NCT02061462
Recruitment Status : Unknown
Verified November 2014 by Franco Valenza, MD, Policlinico Hospital.
Recruitment status was:  Recruiting
First Posted : February 12, 2014
Last Update Posted : November 26, 2014
Sponsor:
Collaborator:
San Gerardo Hospital
Information provided by (Responsible Party):
Franco Valenza, MD, Policlinico Hospital

Brief Summary:
The procurement of organs from donors after cardiocirculatory death (DCD) is an accepted strategy to increase organ supply.

Condition or disease Intervention/treatment Phase
Disorders Related to Lung Transplantation Graft Failure Procedure: EVLP-DCD Group Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Extracorporeal Lung Perfusion and Ventilation to Evaluate the Eligibility for Transplantation of Lungs Retrieved From Donors After Cardio-circulatory Death (DCD)
Study Start Date : October 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard Group
Recipients of lungs procured from brain dead donors.
Active Comparator: EVLP-DCD Group
Recipients of lungs procured from DCD donors, reconditioned/evaluated by EVLP
Procedure: EVLP-DCD Group
Events: application of an open lung protective ventilatory strategy (recruitment manoeuvre, low volume-low frequency ventilation-high PEEP) to the DCD donors; procurement of lungs and cold storage on ice; reconditioning/evaluation by EVLP to assess suitability for transplantation; cold storage on ice; transplantation. Endpoints of suitability: oxygenation, respiratory mechanics, pulmonary vascular resistance, chest X-ray, fibrobronchoscopy




Primary Outcome Measures :
  1. 30 Day Mortality and Graft Survival [ Time Frame: 30 days ]
    30 day mortality and graft survival is used as a standard research measure to evaluate post transplant outcome


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 ]
  3. Primary Graft Dysfunction 72 hours After Transplantation [ Time Frame: 72 hours ]
    Primary Graft Dysfunction 72 hours after transplantation definition: grade 3 according to the International Society of Heart and Lung Transplantation classification


Other Outcome Measures:
  1. Bronchiolitis Obliterans Syndrome (BOS) [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Lung donors:

  • subjects with brain death according to neurological or cardiocirculatory criteria
  • age below 65 yrs
  • absence of massive lung contusion, aspiration, pneumonia, sepsis
  • absence of infection, malignancy

Recipients:

  • subjects to undergo single or bilateral lung transplantation
  • informed consent to participate in the study

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): NCT02061462


Locations
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Italy
Fondazione IRCCS a' Granda - Ospedale Maggiore Policlinico Recruiting
Milan, Italy, 20122
Contact: Franco Valenza, MD    00390255033232    franco.valenza@unimi.it   
Sponsors and Collaborators
Policlinico Hospital
San Gerardo Hospital
Investigators
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Principal Investigator: Franco Valenza, MD Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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Responsible Party: Franco Valenza, MD, Assistant Professor Anaesthesia and Intensive Care, Department of Pathophysilogy and Transplantation, Università degli Studi di Milano, Policlinico Hospital
ClinicalTrials.gov Identifier: NCT02061462     History of Changes
Other Study ID Numbers: EVLP_2013
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: November 26, 2014
Last Verified: November 2014