Trial Outcomes & Findings for Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability (NCT NCT01615484)
NCT ID: NCT01615484
Last Updated: 2018-06-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
30 Days
Results posted on
2018-06-08
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
24
|
|
Overall Study
COMPLETED
|
0
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability
Baseline characteristics by cohort
| Measure |
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
n=24 Participants
No experimental procedures will be carried out.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
—
|
24 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 DaysThe 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.
Outcome measures
| Measure |
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
n=24 Participants
No experimental procedures will be carried out.
|
|---|---|---|
|
30 Day Mortality and Graft Survival
Alive
|
0 Participants
|
22 Participants
|
|
30 Day Mortality and Graft Survival
Deceased
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 24 and 72 hoursPrimary 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.
Outcome measures
| Measure |
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
n=24 Participants
No experimental procedures will be carried out.
|
|---|---|---|
|
Primary Lung Graft Dysfunction (PGD)
Grade 0
|
0 Participants
|
5 Participants
|
|
Primary Lung Graft Dysfunction (PGD)
Grade 1
|
0 Participants
|
9 Participants
|
|
Primary Lung Graft Dysfunction (PGD)
Grade 2
|
0 Participants
|
6 Participants
|
|
Primary Lung Graft Dysfunction (PGD)
Grade 3
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Time to Discharge, up to 30 daysThe length of ICU stay in days is another standard research and clinical outcome assessment post transplant and has been selected as a secondary objective.
Outcome measures
| Measure |
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
n=24 Participants
No experimental procedures will be carried out.
|
|---|---|---|
|
ICU Length of Stay
|
—
|
6.91 Days
Standard Deviation 6.15
|
SECONDARY outcome
Timeframe: 7 Days Post Transplant.Participants' status at Day 7 defined as the following: mechanical ventilation, extra-corporeal membrane oxygenator (ECMO), or extubated.
Outcome measures
| Measure |
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
n=24 Participants
No experimental procedures will be carried out.
|
|---|---|---|
|
Day 7 Ventilator/ECMO Status
Extubated
|
—
|
19 Participants
|
|
Day 7 Ventilator/ECMO Status
Mechanical Ventilator
|
—
|
4 Participants
|
|
Day 7 Ventilator/ECMO Status
ECMO
|
—
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 monthsRecipient mortality at 12 months post transplant is being evaluated as a secondary objective.
Outcome measures
| Measure |
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
n=24 Participants
No experimental procedures will be carried out.
|
|---|---|---|
|
Recipient Mortality at 12 Months
Alive
|
—
|
19 Participants
|
|
Recipient Mortality at 12 Months
Deceased
|
—
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Excludes those who were deceased at Month 12
Bronchiolitis Obliterans Syndrome (BOS) free graft survival at 12 months is being used as a secondary outcome.
Outcome measures
| Measure |
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
n=19 Participants
No experimental procedures will be carried out.
|
|---|---|---|
|
Bronchiolitis Obliterans Syndrome (BOS) Free Graft Survival
BOS-Free
|
—
|
17 Participants
|
|
Bronchiolitis Obliterans Syndrome (BOS) Free Graft Survival
BOS
|
—
|
2 Participants
|
Adverse Events
Ex-vivo Lung Perfusion With STEEN Solution™
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lung Transplant From Conventional Brain-dead Organ Donor
Serious events: 0 serious events
Other events: 16 other events
Deaths: 5 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
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
n=24 participants at risk
No experimental procedures will be carried out.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea and/or vomiting
|
—
0/0 • From the date of transplant through 12 months post-op
|
16.7%
4/24 • Number of events 4 • From the date of transplant through 12 months post-op
|
|
Immune system disorders
Acute Rejection
|
—
0/0 • From the date of transplant through 12 months post-op
|
16.7%
4/24 • Number of events 4 • From the date of transplant through 12 months post-op
|
|
Infections and infestations
Pyrexia
|
—
0/0 • From the date of transplant through 12 months post-op
|
8.3%
2/24 • Number of events 2 • From the date of transplant through 12 months post-op
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
—
0/0 • From the date of transplant through 12 months post-op
|
25.0%
6/24 • Number of events 6 • From the date of transplant through 12 months post-op
|
|
Infections and infestations
Cytomegalovirus (CMV)
|
—
0/0 • From the date of transplant through 12 months post-op
|
8.3%
2/24 • Number of events 2 • From the date of transplant through 12 months post-op
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
—
0/0 • From the date of transplant through 12 months post-op
|
8.3%
2/24 • Number of events 2 • From the date of transplant through 12 months post-op
|
|
Cardiac disorders
Chest pain
|
—
0/0 • From the date of transplant through 12 months post-op
|
8.3%
2/24 • Number of events 2 • From the date of transplant through 12 months post-op
|
|
Gastrointestinal disorders
Diarrhea
|
—
0/0 • From the date of transplant through 12 months post-op
|
8.3%
2/24 • Number of events 2 • From the date of transplant through 12 months post-op
|
|
General disorders
Fatigue
|
—
0/0 • From the date of transplant through 12 months post-op
|
8.3%
2/24 • Number of events 2 • From the date of transplant through 12 months post-op
|
|
General disorders
Dehydration
|
—
0/0 • From the date of transplant through 12 months post-op
|
8.3%
2/24 • Number of events 2 • From the date of transplant through 12 months post-op
|
|
Respiratory, thoracic and mediastinal disorders
Empyema
|
—
0/0 • From the date of transplant through 12 months post-op
|
8.3%
2/24 • Number of events 2 • From the date of transplant through 12 months post-op
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
—
0/0 • From the date of transplant through 12 months post-op
|
8.3%
2/24 • Number of events 2 • From the date of transplant through 12 months post-op
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
—
0/0 • From the date of transplant through 12 months post-op
|
12.5%
3/24 • Number of events 3 • From the date of transplant through 12 months post-op
|
Additional Information
Thomas Egan, MD, MSc, FACS
University of North Carolina at Chapel Hill
Phone: 919-966-3381
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place