EVLP-DCD: EVLP to Evaluate the Eligibility for Transplantation of DCD-Lungs

Sponsor

Policlinico Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02061462

Collaborator

San Gerardo Hospital (Other)

Enrollment

Location

Arms

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Oct 1, 2014

Anticipated Primary Completion Date :

Oct 1, 2016

Anticipated Study Completion Date :

Apr 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

30 Day Mortality and Graft Survival [30 days]
30 day mortality and graft survival is used as a standard research measure to evaluate post transplant outcome

Secondary Outcome Measures

Duration of mechanical ventilation after transplantation [30 days]
ICU length of stay after transplantation [30 days]
Primary Graft Dysfunction 72 hours After Transplantation [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

Bronchiolitis Obliterans Syndrome (BOS) [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione IRCCS a' Granda - Ospedale Maggiore Policlinico	Milan		Italy	20122

Sponsors and Collaborators

Policlinico Hospital
San Gerardo Hospital

Investigators

Principal Investigator: Franco Valenza, MD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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

Other Study ID Numbers:

EVLP_2013

First Posted:

Feb 12, 2014

Last Update Posted:

Nov 26, 2014

Last Verified:

Nov 1, 2014

Study Results

No Results Posted as of Nov 26, 2014