Lung DiseaseNCT02234128
Extending Preservation and Assessment Time of Donor Lungs Using the Toronto EVLP System™ at a Dedicated EVLP Facility
A study testing Toronto EVLP System™ in people with Lung Disease, run by Lung Bioengineering Inc. at 8 sites in United States.
Trial summary
This is a safety study to compare the safety of receiving a lung treated with the Toronto EVLP System™ by SPONSOR in SPONSOR's dedicated facility against standard lung transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Disease
- What is being tested?
- Toronto EVLP System™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 8 sitesUnited States
- Study dates
- 18 Jul 2015to 7 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Subject Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Male or female patients
- All patients, 18 years of age or older
- Patient already on or added to the active waiting list for a single or bilateral lung transplant
- Patient or patient's representative provides informed consent for participation in the study at the time of study commencement or time of listing for transplant
- Patient or patient's representative reconfirms informed consent for the study on the day of lung transplant
Subject Exclusion Criteria:
A subject who meets any of the following criteria will be excluded from participation:
- Patients listed for same-side lung re-transplantation
- Patients listed for multiple organ transplantation including lung and any other organ
- Patients listed for live donor lobar transplant
- Patients with HIV, active Hepatitis B/C, or Burkholderia Cepacia
- Patients not initially consented into the study prior to the time of lung transplant
- Patients in the ICU at the time of initial lung offer requiring mechanical ventilation, ECMO or other Extracorporeal life support (ECLS).
Donor Lung Inclusion Criteria for EVLP Assessment:
The donor lung must meet at least one of the following criteria to proceed with EVLP:
- At the time of the clinical evaluation, the donor PaO2/FiO2 < 300 mmHg
- Donor received ≥ 10 units of blood transfusions
- Donation after Cardiac Death (DCD) donor
- Expected cold ischemic time > 6 hours
- Donor age ≥ 55 years old
- Study Center Investigator requires additional assessment ex vivo and/or extended preservation time
Donor Lung Exclusion Criteria for EVLP Assessment:
The donor lung is excluded from EVLP if at least one of the following criteria have been met:
- The donor lung has confirmed pneumonia and/or persistent purulent secretions identified via bronchoscopy
- Non-persistent purulent secretions that do not clear by hour 3 on EVLP
- The donor lung has confirmed evidence of aspiration
- The donor lung has significant mechanical lung injury or trauma
- The cold ischemic time, starting at donor aortic cross clamp/ initial flush (CIT-1), required to transport the lung from the donor site to start of the EVLP procedure at SPONSOR's facility > 10 hours
EVLP Lung Inclusion Criteria for Transplantation:
The donor lung must meet each of the following conditions post-EVLP for transplant suitability consideration by the Study Center Investigator:
- PvO2/FiO2 ≥ 350 mmHg at final EVLP evaluation time period
- and < 15% increase from baseline value (defined as the first hour collection point) to final value of pulmonary vascular resistance (PVR)
- and < 15% increase from baseline value to final value of peak airway pressure (PawP)
- and < 15% decrease from baseline value to final value of static lung compliance (Cstat)
- and the total preservation time (TPT) does not exceed the following:
- the initial CIT-1 time from donor to EVLP > 1 hour and ≤ 10 hours
- the EVLP time > 3 hours and ≤ 6 hours
- the second CIT-2 from EVLP cool down to beginning of recipient implantation must be > 1 hour and ≤ 6 hours for the first lung
- the second CIT-2 from EVLP cool down to beginning of recipient implantation must be > 1 hour and ≤ 10 hours for the second lung
- and Study Center Investigator deems lung function suitable for intended subject
EVLP Lung Exclusion Criteria for Transplantation:
The donor lung is excluded from transplant inclusion if at least one of the following criteria have been met:
- PvO2/FiO2 < 350 mmHg at final EVLP evaluation time period
- or ≥ 15% increase from baseline value to final value of pulmonary vascular resistance (PVR)
- or ≥ 15% increase from baseline value to final value of peak airway pressure (PawP)
- or ≥ 15% decrease from baseline value to final value of static lung compliance (Cstat)
- or TPT exceeds any of the following conditions:
- CIT-1 < 1 hour or > 10 hours
- EVLP < 3 hours or > 6 hours
- CIT-2 < 1 hour or > 6 hours for first lung or > 10 hours for second lung
- or Study Center investigator deems lung function unsuitable for intended subject
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
University of Maryland Medical Center
Baltimore, Maryland, 21201
Loyola University Medical Center
Chicago, Illinois, 60153
Cleveland Clinic
Cleveland, Ohio, 44195
Duke University Health System
Durham, North Carolina, 27705
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Phase 2, Multicenter, Open-label Study to Measure the Safety of Extending Preservation and Assessment Time of Donor Lungs Using Normothermic Ex Vivo Lung Perfusion and Ventilation (EVLP) as Administered by the SPONSOR Using the Toronto EVLP System™
This is a safety study to compare the safety of receiving a lung treated with the Toronto EVLP System™ by SPONSOR in SPONSOR's dedicated facility against standard lung transplantation.
Read the detailed description
Human donor lungs allocated to a participating study transplant center (Study Center) for a specific recipient and meeting study EVLP donor lung inclusion/exclusion criteria will be assessed by SPONSOR for inclusion into the study.
Upon retrieval, donor lung(s) will be packaged and transported on ice to the SPONSOR's EVLP facility in Silver Spring, Maryland, no differently than when lungs are recovered, packaged, and transported to any transplant center for implantation.
The EVLP procedure will be performed by Certified Ex Vivo Lung Specialists using the Toronto EVLP System™ for up to 6 hours, collecting and relaying lung function assessment data hourly or as requested by the Study Center transplant surgeon. Additionally, the Study Center surgeon will have the capability to evaluate lung function data and monitor the procedure remotely through a dedicated video link.
Upon acceptance of an EVLP donor lung by the Study Center, the single lung or lung block is cooled down by the Toronto EVLP System™ to 10 degrees C. Thereafter, perfusion and ventilation are stopped and the lung is prepared for hypothermic storage and transport to the accepting Study Center.
- Conditions
- Lung Disease
- Being tested
- Toronto EVLP System™
- Keywords
- Ex Vivo Lung Perfusion, EVLP, Lung Transplant, Lung Transplantation, Toronto EVLP System™, PERFUSIX
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toronto EVLP System™Device
Extending preservation and assessment time of donor lungs using the Toronto EVLP System
| Study group | Role | What they receive |
|---|---|---|
| EVLP Double Lung Group | Experimental | Toronto EVLP System™ administered to double lungs. Receives: Device: Toronto EVLP System™ |
| EVLP Single Lung Group | Experimental | Toronto EVLP System™ administered to single lungs. Receives: Device: Toronto EVLP System™ |
| Control Group | No intervention | Those patients receiving a single or double lung via conventional transplant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of Participants With Primary Graft Dysfunction (PGD), Grade 3
Primary Graft Dysfunction is a scale published by the International Society of Heart and Lung Transplantation that uses patient oxygenation and radiographic results to score patients on a 0 (zero) to 3 (three) scale, with 3 being the most significant dysfunction.
Measured: 72 Hours
Count of Participants Surviving
The number of participants that survived to 30 days post-transplant.
Measured: 30 Days
Secondary outcomes (5)
PGD Score
Primary Graft Dysfunction is a scale published by the International Society of Heart and Lung Transplantation that uses patient oxygenation and radiographic results to score patients on a 0 (zero) to 3 (three) scale, with 3 being the most significant dysfunction. PGD Score (0-3) was determined at 0, 24, 48 \& 72 hours post-transplant
Measured: 0, 24, 48 & 72 Hours
ICU Length of Stay
Number of days in Intensive Care Unit post transplant.
Measured: One year
Total Lung Preservation Time (TPT)
Time in hours between cross-clamp in donor and reperfusion in recipient.
Measured: 72 Hours
Time to First Extubation
Number of hours from admission to ICU post-transplant to extubation of the participant.
Measured: One year
Hospital Length of Stay
Duration of primary hospital stay in days.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study start18 Jul 2015
- Primary completion21 Nov 2018
- Study completion7 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lung Bioengineering Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234128
- Sponsor's protocol ID
- PXUS-14-001
- Other IDs
- 4766
- Status last verified
- Apr 2026
- First submitted
- 4 Sep 2014
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pierre AF, Sekine Y, Hutcheon MA, Waddell TK, Keshavjee SH. Marginal donor lungs: a reassessment. J Thorac Cardiovasc Surg. 2002 Mar;123(3):421-7; discussion, 427-8. doi: 10.1067/mtc.2002.120345.
PubMed 11882811Ware LB, Wang Y, Fang X, Warnock M, Sakuma T, Hall TS, Matthay M. Assessment of lungs rejected for transplantation and implications for donor selection. Lancet. 2002 Aug 24;360(9333):619-20. doi: 10.1016/s0140-6736(02)09774-x.
PubMed 12241936Orens JB, Boehler A, de Perrot M, Estenne M, Glanville AR, Keshavjee S, Kotloff R, Morton J, Studer SM, Van Raemdonck D, Waddel T, Snell GI; Pulmonary Council, International Society for Heart and Lung Transplantation. A review of lung transplant donor acceptability criteria. J Heart Lung Transplant. 2003 Nov;22(11):1183-200. doi: 10.1016/s1053-2498(03)00096-2. No abstract available.
PubMed 14585380Kawut SM, Reyentovich A, Wilt JS, Anzeck R, Lederer DJ, O'Shea MK, Sonett JR, Arcasoy SM. Outcomes of extended donor lung recipients after lung transplantation. Transplantation. 2005 Feb 15;79(3):310-6. doi: 10.1097/01.tp.0000149504.53710.ae.
PubMed 15699761Christie JD, Carby M, Bag R, Corris P, Hertz M, Weill D; ISHLT Working Group on Primary Lung Graft Dysfunction. Report of the ISHLT Working Group on Primary Lung Graft Dysfunction part II: definition. A consensus statement of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2005 Oct;24(10):1454-9. doi: 10.1016/j.healun.2004.11.049. Epub 2005 Jun 4. No abstract available.
PubMed 16210116Botha P, Trivedi D, Weir CJ, Searl CP, Corris PA, Dark JH, Schueler SV. Extended donor criteria in lung transplantation: impact on organ allocation. J Thorac Cardiovasc Surg. 2006 May;131(5):1154-60. doi: 10.1016/j.jtcvs.2005.12.037.
PubMed 16678604Avlonitis VS, Wigfield CH, Golledge HD, Kirby JA, Dark JH. Early hemodynamic injury during donor brain death determines the severity of primary graft dysfunction after lung transplantation. Am J Transplant. 2007 Jan;7(1):83-90. doi: 10.1111/j.1600-6143.2006.01593.x.
PubMed 17227559Suzuki Y, Cantu E, Christie JD. Primary graft dysfunction. Semin Respir Crit Care Med. 2013 Jun;34(3):305-319. doi: 10.1055/s-0033-1348474. Epub 2013 Jul 2.
PubMed 23821506Bennett M, Horton S, Thuys C, Augustin S, Rosenberg M, Brizard C. Pump-induced haemolysis: a comparison of short-term ventricular assist devices. Perfusion. 2004 Mar;19(2):107-11. doi: 10.1191/0267659104pf729oa.
PubMed 15162925Watanabe N, Sakota D, Ohuchi K, Takatani S. Deformability of red blood cells and its relation to blood trauma in rotary blood pumps. Artif Organs. 2007 May;31(5):352-8. doi: 10.1111/j.1525-1594.2007.00392.x.
PubMed 17470204Lyu DM, Zamora MR. Medical complications of lung transplantation. Proc Am Thorac Soc. 2009 Jan 15;6(1):101-7. doi: 10.1513/pats.200808-077GO.
PubMed 19131535Cypel M, Yeung JC, Hirayama S, Rubacha M, Fischer S, Anraku M, Sato M, Harwood S, Pierre A, Waddell TK, de Perrot M, Liu M, Keshavjee S. Technique for prolonged normothermic ex vivo lung perfusion. J Heart Lung Transplant. 2008 Dec;27(12):1319-25. doi: 10.1016/j.healun.2008.09.003.
PubMed 19059112Cypel M, Rubacha M, Yeung J, Hirayama S, Torbicki K, Madonik M, Fischer S, Hwang D, Pierre A, Waddell TK, de Perrot M, Liu M, Keshavjee S. Normothermic ex vivo perfusion prevents lung injury compared to extended cold preservation for transplantation. Am J Transplant. 2009 Oct;9(10):2262-9. doi: 10.1111/j.1600-6143.2009.02775.x. Epub 2009 Aug 6.
PubMed 19663886Cypel M, Liu M, Rubacha M, Yeung JC, Hirayama S, Anraku M, Sato M, Medin J, Davidson BL, de Perrot M, Waddell TK, Slutsky AS, Keshavjee S. Functional repair of human donor lungs by IL-10 gene therapy. Sci Transl Med. 2009 Oct 28;1(4):4ra9. doi: 10.1126/scitranslmed.3000266.
PubMed 20368171Cypel M, Sato M, Yildirim E, Karolak W, Chen F, Yeung J, Boasquevisque C, Leist V, Singer LG, Yasufuku K, Deperrot M, Waddell TK, Keshavjee S, Pierre A. Initial experience with lung donation after cardiocirculatory death in Canada. J Heart Lung Transplant. 2009 Aug;28(8):753-8. doi: 10.1016/j.healun.2009.05.009. Epub 2009 Jun 28.
PubMed 19632569
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Open-label Study to Measure the Safety of Extending Preservation and Assessment Time of Donor Lungs Using Normothermic Ex Vivo Lung Perfusion and Ventilation (EVLP) as Administered by the SPONSOR Using the Toronto EVLP System™
- ClinicalTrials.gov ID
- NCT02234128
- Acronym / sponsor ID
- PXUS-14-001
- Conditions
- Lung Disease
- Keywords
- Ex Vivo Lung Perfusion, EVLP, Lung Transplant, Lung Transplantation, Toronto EVLP System™, PERFUSIX
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Lung Bioengineering Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Jul 2015 (actual)
- Primary completion
- 21 Nov 2018 (actual)
- Study completion
- 7 Nov 2019 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Posted 9 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a safety study to compare the safety of receiving a lung treated with the Toronto EVLP System™ by SPONSOR in SPONSOR's dedicated facility against standard lung transplantation.
Detailed description
Human donor lungs allocated to a participating study transplant center (Study Center) for a specific recipient and meeting study EVLP donor lung inclusion/exclusion criteria will be assessed by SPONSOR for inclusion into the study.
Upon retrieval, donor lung(s) will be packaged and transported on ice to the SPONSOR's EVLP facility in Silver Spring, Maryland, no differently than when lungs are recovered, packaged, and transported to any transplant center for implantation.
The EVLP procedure will be performed by Certified Ex Vivo Lung Specialists using the Toronto EVLP System™ for up to 6 hours, collecting and relaying lung function assessment data hourly or as requested by the Study Center transplant surgeon. Additionally, the Study Center surgeon will have the capability to evaluate lung function data and monitor the procedure remotely through a dedicated video link.
Upon acceptance of an EVLP donor lung by the Study Center, the single lung or lung block is cooled down by the Toronto EVLP System™ to 10 degrees C. Thereafter, perfusion and ventilation are stopped and the lung is prepared for hypothermic storage and transport to the accepting Study Center.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EVLP Double Lung Group | Experimental | Device: Toronto EVLP System™Toronto EVLP System™ administered to double lungs. |
| EVLP Single Lung Group | Experimental | Device: Toronto EVLP System™Toronto EVLP System™ administered to single lungs. |
| Control Group | No intervention | –Those patients receiving a single or double lung via conventional transplant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toronto EVLP System™Extending preservation and assessment time of donor lungs using the Toronto EVLP System | Device | EVLP Double Lung Group, EVLP Single Lung Group |
Primary outcome
Count of Participants With Primary Graft Dysfunction (PGD), Grade 3
Time frame: 72 Hours
Primary Graft Dysfunction is a scale published by the International Society of Heart and Lung Transplantation that uses patient oxygenation and radiographic results to score patients on a 0 (zero) to 3 (three) scale, with 3 being the most significant dysfunction.
Count of Participants Surviving
Time frame: 30 Days
The number of participants that survived to 30 days post-transplant.
5 secondary outcomes
PGD Score
Time frame: 0, 24, 48 & 72 Hours
ICU Length of Stay
Time frame: One year
Total Lung Preservation Time (TPT)
Time frame: 72 Hours
Time to First Extubation
Time frame: One year
Hospital Length of Stay
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11882811Pierre AF, Sekine Y, Hutcheon MA, Waddell TK, Keshavjee SH. Marginal donor lungs: a reassessment. J Thorac Cardiovasc Surg. 2002 Mar;123(3):421-7; discussion, 427-8. doi: 10.1067/mtc.2002.120345.
- Background: PubMed 12241936Ware LB, Wang Y, Fang X, Warnock M, Sakuma T, Hall TS, Matthay M. Assessment of lungs rejected for transplantation and implications for donor selection. Lancet. 2002 Aug 24;360(9333):619-20. doi: 10.1016/s0140-6736(02)09774-x.
- Background: PubMed 14585380Orens JB, Boehler A, de Perrot M, Estenne M, Glanville AR, Keshavjee S, Kotloff R, Morton J, Studer SM, Van Raemdonck D, Waddel T, Snell GI; Pulmonary Council, International Society for Heart and Lung Transplantation. A review of lung transplant donor acceptability criteria. J Heart Lung Transplant. 2003 Nov;22(11):1183-200. doi: 10.1016/s1053-2498(03)00096-2. No abstract available.
- Background: PubMed 15699761Kawut SM, Reyentovich A, Wilt JS, Anzeck R, Lederer DJ, O'Shea MK, Sonett JR, Arcasoy SM. Outcomes of extended donor lung recipients after lung transplantation. Transplantation. 2005 Feb 15;79(3):310-6. doi: 10.1097/01.tp.0000149504.53710.ae.
- Background: PubMed 16210116Christie JD, Carby M, Bag R, Corris P, Hertz M, Weill D; ISHLT Working Group on Primary Lung Graft Dysfunction. Report of the ISHLT Working Group on Primary Lung Graft Dysfunction part II: definition. A consensus statement of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2005 Oct;24(10):1454-9. doi: 10.1016/j.healun.2004.11.049. Epub 2005 Jun 4. No abstract available.
- Background: PubMed 16678604Botha P, Trivedi D, Weir CJ, Searl CP, Corris PA, Dark JH, Schueler SV. Extended donor criteria in lung transplantation: impact on organ allocation. J Thorac Cardiovasc Surg. 2006 May;131(5):1154-60. doi: 10.1016/j.jtcvs.2005.12.037.
- Background: PubMed 17227559Avlonitis VS, Wigfield CH, Golledge HD, Kirby JA, Dark JH. Early hemodynamic injury during donor brain death determines the severity of primary graft dysfunction after lung transplantation. Am J Transplant. 2007 Jan;7(1):83-90. doi: 10.1111/j.1600-6143.2006.01593.x.
- Background: PubMed 23821506Suzuki Y, Cantu E, Christie JD. Primary graft dysfunction. Semin Respir Crit Care Med. 2013 Jun;34(3):305-319. doi: 10.1055/s-0033-1348474. Epub 2013 Jul 2.
- Background: PubMed 15162925Bennett M, Horton S, Thuys C, Augustin S, Rosenberg M, Brizard C. Pump-induced haemolysis: a comparison of short-term ventricular assist devices. Perfusion. 2004 Mar;19(2):107-11. doi: 10.1191/0267659104pf729oa.
- Background: PubMed 17470204Watanabe N, Sakota D, Ohuchi K, Takatani S. Deformability of red blood cells and its relation to blood trauma in rotary blood pumps. Artif Organs. 2007 May;31(5):352-8. doi: 10.1111/j.1525-1594.2007.00392.x.
- Background: PubMed 19131535Lyu DM, Zamora MR. Medical complications of lung transplantation. Proc Am Thorac Soc. 2009 Jan 15;6(1):101-7. doi: 10.1513/pats.200808-077GO.
- Background: PubMed 19059112Cypel M, Yeung JC, Hirayama S, Rubacha M, Fischer S, Anraku M, Sato M, Harwood S, Pierre A, Waddell TK, de Perrot M, Liu M, Keshavjee S. Technique for prolonged normothermic ex vivo lung perfusion. J Heart Lung Transplant. 2008 Dec;27(12):1319-25. doi: 10.1016/j.healun.2008.09.003.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toronto EVLP System™ in people with Lung Disease, run by Lung Bioengineering Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Count of Participants With Primary Graft Dysfunction (PGD), Grade 3 (time frame: 72 Hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02234128, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.