ClinicalTrials.gov
ClinicalTrials.gov Menu

Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability

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: NCT01615484
Recruitment Status : Completed
First Posted : June 8, 2012
Results First Posted : April 20, 2018
Last Update Posted : April 20, 2018
Sponsor:
Collaborators:
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Vitrolife
XVIVO Perfusion
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Emphysema
Chronic Obstructive Pulmonary Disease (COPD)
Cystic Fibrosis
Pulmonary Fibrosis
Bronchiectasis
Sarcoidosis
Pulmonary Hypertension
Alpha-1 Antitrypsin Deficiency
Interventions: Procedure: Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™
Device: STEEN Solution™

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ex-vivo Lung Perfusion With STEEN Solution™ Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ and CT scan.
Lung Transplant From Conventional Brain-dead Organ Donor No experimental procedures will be carried out.

Participant Flow:   Overall Study
    Ex-vivo Lung Perfusion With STEEN Solution™   Lung Transplant From Conventional Brain-dead Organ Donor
STARTED   0   24 
COMPLETED   0   24 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ex-vivo Lung Perfusion With STEEN Solution™ Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ and CT scan.
Lung Transplant From Conventional Brain-dead Organ Donor No experimental procedures will be carried out.
Total Total of all reporting groups

Baseline Measures
   Ex-vivo Lung Perfusion With STEEN Solution™   Lung Transplant From Conventional Brain-dead Organ Donor   Total 
Overall Participants Analyzed 
[Units: Participants]
 0   24   24 
Age 
[Units: Participants]
Count of Participants
     
<=18 years   0      0   0.0%      0   0.0% 
Between 18 and 65 years   0      12  50.0%      12  50.0% 
>=65 years   0      12  50.0%      12  50.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female   0      9  37.5%      9  37.5% 
Male   0      15  62.5%      15  62.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native   0      0   0.0%      0   0.0% 
Asian   0      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander   0      0   0.0%      0   0.0% 
Black or African American   0      4  16.7%      4  16.7% 
White   0      20  83.3%      20  83.3% 
More than one race   0      0   0.0%      0   0.0% 
Unknown or Not Reported   0      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States      24   24 


  Outcome Measures

1.  Primary:   30 Day Mortality and Graft Survival   [ Time Frame: 30 Days ]

2.  Primary:   Primary Lung Graft Dysfunction (PGD)   [ Time Frame: 24 and 72 hours ]

3.  Secondary:   ICU Length of Stay   [ Time Frame: Time to Discharge ]

4.  Secondary:   Day 7 Ventilator/ECMO Status   [ Time Frame: 7 Days Post Transplant. ]

5.  Secondary:   Recipient Mortality at 12 Months   [ Time Frame: 12 months ]

6.  Secondary:   Bronchiolitis Obliterans Syndrome (BOS) Free Graft Survival   [ Time Frame: 12 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Lungs were recovered from 35 NHBDs, 22 had EVLP. 2 lung blocks were judged suitable for transplant. No consented recipient was available for one, the other could not be done for logistical reasons; so there were no subjects in the interventional arm.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Thomas Egan, MD, MSc, FACS
Organization: University of North Carolina at Chapel Hill
phone: 919-966-3381
e-mail: thomas_egan@med.unc.edu


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01615484     History of Changes
Other Study ID Numbers: UNC-002 Vitrolife
1UM1HL113115-01A1 ( U.S. NIH Grant/Contract )
First Submitted: June 6, 2012
First Posted: June 8, 2012
Results First Submitted: March 21, 2018
Results First Posted: April 20, 2018
Last Update Posted: April 20, 2018