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Trial record 16 of 20 for:    evlp

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

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ClinicalTrials.gov Identifier: NCT01615484
Recruitment Status : Completed
First Posted : June 8, 2012
Results First Posted : April 20, 2018
Last Update Posted : June 8, 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™
Enrollment 24
Recruitment Details  
Pre-assignment Details Lungs were recovered from 35 NHBDs, 22 had EVLP. Two lung blocks were judged suitable, but not transplanted: No consented recipient available for #1, protocol time specifications could not be met for #2. As such, no subjects enrolled into EVLP arm.
Arm/Group Title Ex-vivo Lung Perfusion With STEEN Solution™ Lung Transplant From Conventional Brain-dead Organ Donor
Hide Arm/Group Description Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ and CT scan. No experimental procedures will be carried out.
Period Title: Overall Study
Started 0 24
Completed 0 24
Not Completed 0 0
Arm/Group Title Ex-vivo Lung Perfusion With STEEN Solution™ Lung Transplant From Conventional Brain-dead Organ Donor Total
Hide Arm/Group Description Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ and CT scan. No experimental procedures will be carried out. Total of all reporting groups
Overall Number of Baseline Participants 0 24 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 24 participants 24 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 24 participants 24 participants
Female 0
9
  37.5%
9
  37.5%
Male 0
15
  62.5%
15
  62.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 24 participants 24 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  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 0 participants 24 participants 24 participants
24
 100.0%
24
 100.0%
1.Primary Outcome
Title 30 Day Mortality and Graft Survival
Hide Description The primary objective evaluated for this study is recipient mortality and graft survival at 30 days post transplant. 30 day mortality and graft survival is used as a standard research assessment to evaluate post transplant outcomes.
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ex-vivo Lung Perfusion With STEEN Solution™ Lung Transplant From Conventional Brain-dead Organ Donor
Hide Arm/Group Description:
Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ and CT scan.
No experimental procedures will be carried out.
Overall Number of Participants Analyzed 0 24
Measure Type: Count of Participants
Unit of Measure: Participants
Alive 0
22
  91.7%
Deceased 0
2
   8.3%
2.Primary Outcome
Title Primary Lung Graft Dysfunction (PGD)
Hide Description

Primary Lung Graft Dysfunction (PGD) is an indicator for significant morbidity and mortality after lung transplantation.

Grade 0: PaO2/FIO2 > 300 with normal chest radiograph; Grade 1: PaO2/FIO2 > 300 with diffuse infiltrates on the chest radiograph; Grade 2: PaO2/FIO2 between 200 and 300; Grade 3: PaO2/FIO2 < 200.

Time Frame 24 and 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ex-vivo Lung Perfusion With STEEN Solution™ Lung Transplant From Conventional Brain-dead Organ Donor
Hide Arm/Group Description:
Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ and CT scan.
No experimental procedures will be carried out.
Overall Number of Participants Analyzed 0 24
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 0 0
5
  20.8%
Grade 1 0
9
  37.5%
Grade 2 0
6
  25.0%
Grade 3 0
4
  16.7%
3.Secondary Outcome
Title ICU Length of Stay
Hide Description The length of ICU stay in days is another standard research and clinical outcome assessment post transplant and has been selected as a secondary objective.
Time Frame Time to Discharge, up to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ex-vivo Lung Perfusion With STEEN Solution™ Lung Transplant From Conventional Brain-dead Organ Donor
Hide Arm/Group Description:
Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ and CT scan.
No experimental procedures will be carried out.
Overall Number of Participants Analyzed 0 24
Mean (Standard Deviation)
Unit of Measure: Days
6.91  (6.15)
4.Secondary Outcome
Title Day 7 Ventilator/ECMO Status
Hide Description Participants' status at Day 7 defined as the following: mechanical ventilation, extra-corporeal membrane oxygenator (ECMO), or extubated.
Time Frame 7 Days Post Transplant.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ex-vivo Lung Perfusion With STEEN Solution™ Lung Transplant From Conventional Brain-dead Organ Donor
Hide Arm/Group Description:
Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ and CT scan.
No experimental procedures will be carried out.
Overall Number of Participants Analyzed 0 24
Measure Type: Count of Participants
Unit of Measure: Participants
Mechanical Ventilator
4
  16.7%
ECMO
1
   4.2%
Extubated
19
  79.2%
5.Secondary Outcome
Title Recipient Mortality at 12 Months
Hide Description Recipient mortality at 12 months post transplant is being evaluated as a secondary objective.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ex-vivo Lung Perfusion With STEEN Solution™ Lung Transplant From Conventional Brain-dead Organ Donor
Hide Arm/Group Description:
Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ and CT scan.
No experimental procedures will be carried out.
Overall Number of Participants Analyzed 0 24
Measure Type: Count of Participants
Unit of Measure: Participants
Alive
19
  79.2%
Deceased
5
  20.8%
6.Secondary Outcome
Title Bronchiolitis Obliterans Syndrome (BOS) Free Graft Survival
Hide Description Bronchiolitis Obliterans Syndrome (BOS) free graft survival at 12 months is being used as a secondary outcome.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Excludes those who were deceased at Month 12
Arm/Group Title Ex-vivo Lung Perfusion With STEEN Solution™ Lung Transplant From Conventional Brain-dead Organ Donor
Hide Arm/Group Description:
Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ and CT scan.
No experimental procedures will be carried out.
Overall Number of Participants Analyzed 0 19
Measure Type: Count of Participants
Unit of Measure: Participants
BOS-Free
17
  89.5%
BOS
2
  10.5%
Time Frame From the date of transplant through 12 months post-op
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ex-vivo Lung Perfusion With STEEN Solution™ Lung Transplant From Conventional Brain-dead Organ Donor
Hide Arm/Group Description Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ and CT scan. No experimental procedures will be carried out.
All-Cause Mortality
Ex-vivo Lung Perfusion With STEEN Solution™ Lung Transplant From Conventional Brain-dead Organ Donor
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0      5/24 (20.83%)    
Show Serious Adverse Events Hide Serious Adverse Events
Ex-vivo Lung Perfusion With STEEN Solution™ Lung Transplant From Conventional Brain-dead Organ Donor
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/24 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ex-vivo Lung Perfusion With STEEN Solution™ Lung Transplant From Conventional Brain-dead Organ Donor
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      16/24 (66.67%)    
Cardiac disorders     
Chest pain *  0/0  0 2/24 (8.33%)  2
Gastrointestinal disorders     
Nausea and/or vomiting *  0/0  0 4/24 (16.67%)  4
Gastroesophageal Reflux Disease *  0/0  0 6/24 (25.00%)  6
Diarrhea *  0/0  0 2/24 (8.33%)  2
General disorders     
Fatigue *  0/0  0 2/24 (8.33%)  2
Dehydration *  0/0  0 2/24 (8.33%)  2
Immune system disorders     
Acute Rejection *  0/0  0 4/24 (16.67%)  4
Infections and infestations     
Pyrexia *  0/0  0 2/24 (8.33%)  2
Cytomegalovirus (CMV) *  0/0  0 2/24 (8.33%)  2
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism *  0/0  0 2/24 (8.33%)  2
Empyema *  0/0  0 2/24 (8.33%)  2
Respiratory failure *  0/0  0 2/24 (8.33%)  2
Dyspnea *  0/0  0 3/24 (12.50%)  3
*
Indicates events were collected by non-systematic assessment
Lungs recovered from 35 NHBDs, 22 had EVLP. Two lung blocks judged suitable, but not transplanted: no consented recipient available for #1, protocol time specifications could not be met for #2. As such, no subjects enrolled into EVLP arm.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Thomas Egan, MD, MSc, FACS
Organization: University of North Carolina at Chapel Hill
Phone: 919-966-3381
EMail: thomas_egan@med.unc.edu
Publications:
Layout table for additonal information
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: June 8, 2018