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AzTrials

Lung TransplantationPhase 1HELPNCT01190059

Normothermic Ex Vivo Lung Perfusion (EVLP) For An Improved Assessment of Donor Lungs For Transplantation

A Phase 1 study testing Ex vivo lung perfusion with Steen Solution™ in people with Lung Transplantation, run by XVIVO Perfusion at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The use of ex vivo lung perfusion (EVLP) will allow for a secondary evaluation technique for donor lungs that fail to meet standard acceptability criteria. This advanced assessment might lead to increased utilization rates of donor lungs and improved outcomes after lung transplantation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Transplantation
What is being tested?
Ex vivo lung perfusion with Steen Solution™
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteCanada
Study dates
Aug 2008to Feb 2010
Phase
Phase 1
Are there results?
None posted in the registry

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

Who may be able to join

  • Recipient to undergo a single or bilateral Lung Transplantation
  • Last donor PaO2/FiO2 ≤ 300mmHg
  • Poor oxygenation and/or poor lung compliance is the primary reason for unsuitability
  • Absence of pneumonia, persistent purulent secretion on bronchoscopy or significant mechanical trauma

Who cannot join

  • Infection
  • Aspiration
  • Significant mechanical lung injury - contusion
  • Infectious diseases : HIV, Hepatitis B and C, HTLV \& Syphilis
  • Malignancy

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Toronto General Hospital

    Toronto, Ontario, M5G 1Z5

Other trials in Canada

About this study

The use of ex vivo lung perfusion (EVLP) will allow for a secondary evaluation technique for donor lungs that fail to meet standard acceptability criteria. This advanced assessment might lead to increased utilization rates of donor lungs and improved outcomes after lung transplantation.

Read the detailed description

Human donor lungs that do not meet the standard clinical criteria for donor lung utilization but fit into the study inclusion criteria will be retrieved from the donor using current donor lung retrieval techniques.

These lungs will be brought to the study transplant center to be re-assessed by the transplant team. The lungs will be physiologically assessed during ex vivo perfusion with Steen Solution. Perfusion of these lungs will be performed using Steen solution with the addition of methylprednisolone, heparin and antibiotics. With respect to the decision of lung utilization those organs with a delta pO2 (Δ pO2 = Pulmonary vein pO2 - pulmonary artery pO2) during ex vivo perfusion assessment > 350mmHg, good lung compliance, and a favorable opinion of the transplant surgeon will be considered transplantable. Lungs will be excluded for transplantation: if the Δ pO2 is less than 350mmHg or if they demonstrate >10% deterioration in any of the following functional parameters: pulmonary vascular resistance (PVR), dynamic compliance or airway pressures. Lungs will also be excluded if they are deemed unsuitable based on the clinical judgment of the lung transplant surgeon.

Being tested
Ex vivo lung perfusion with Steen Solution™
Keywords
Lung, Transplantation, Lung Transplantation, Transplantation Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ex vivo lung perfusion with Steen Solution™Drug

    The circuit is primed with 2,000cc Steen Solution™. At one hour of EVLP, 500 cc of circulated perfusate was removed and replenished with 500 cc of fresh perfusate. After that, 250 cc of perfusate was exchanged every hour.

Study groups in NCT01190059
Study groupRoleWhat they receive
EVLP GroupExperimentalEVLP Group are those recipient lung transplant patients that received donor lungs that had been placed on the ex vivo lung perfusion system with Steen Solution™ .
Receives: Drug: Ex vivo lung perfusion with Steen Solution™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PGD scores in the first 72 hours after lung transplantation.

    Immediate lung function is one of the key factors in determining the impact of donor lung quality, therefore the PGD score within 72 hrs was selected as the primary endpoint.

    Measured: 72 hours

  2. 30 day Mortality

    Mortality at 30 days post transplant

    Measured: 30 days

Secondary outcomes (5)

  1. Extra-corporeal membrane oxygenation use

    If the patient needed to be placed on extra-corporeal membrane oxygenation after transplantation.

    Measured: 30 days

  2. Bronchial complications

    To see if there was an increased risk for bronchial complications

    Measured: 30 days

  3. Ventilator duration

    How long was the patient on the ventilator after lung transplantation and was there an increased time on ventilator for the patient after EVLP.

    Measured: 30 days

  4. Intensive Care Unit length of stay

    Measured: 30 days

  5. Hospital length of stay

    Time in the hospital

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2010 (estimated)
  2. Study startAug 2008
  3. Primary completionFeb 2010
  4. Study completionFeb 2010

Resources

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 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01190059
Sponsor's protocol ID
VIT-001-TOR
Other IDs
139150
Acronym
HELP
Status last verified
Apr 2025
First submitted
25 Aug 2010
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
Yes

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 11882811

  • de Perrot M, Liu M, Waddell TK, Keshavjee S. Ischemia-reperfusion-induced lung injury. Am J Respir Crit Care Med. 2003 Feb 15;167(4):490-511. doi: 10.1164/rccm.200207-670SO.

    PubMed 12588712

  • Cypel 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 19663886

  • D.M. Karamanou, H.R. Walden, S. Bean, et al. The Effect of Ex-Vivo Perfusion on the Inflammatory Profile of the Donor Lung. J Heart Lung Transplant 2010:Vol. 29, Issue 2, Supplement, Page S165.

  • Inci I, Ampollini L, Arni S, Jungraithmayr W, Inci D, Hillinger S, Leskosek B, Vogt P, Weder W. Ex vivo reconditioning of marginal donor lungs injured by acid aspiration. J Heart Lung Transplant. 2008 Nov;27(11):1229-36. doi: 10.1016/j.healun.2008.07.027. Epub 2008 Oct 1.

    PubMed 18971096

  • Steen S, Sjoberg T, Pierre L, Liao Q, Eriksson L, Algotsson L. Transplantation of lungs from a non-heart-beating donor. Lancet. 2001 Mar 17;357(9259):825-9. doi: 10.1016/S0140-6736(00)04195-7.

    PubMed 11265950

  • Ingemansson R, Eyjolfsson A, Mared L, Pierre L, Algotsson L, Ekmehag B, Gustafsson R, Johnsson P, Koul B, Lindstedt S, Luhrs C, Sjoberg T, Steen S. Clinical transplantation of initially rejected donor lungs after reconditioning ex vivo. Ann Thorac Surg. 2009 Jan;87(1):255-60. doi: 10.1016/j.athoracsur.2008.09.049.

    PubMed 19101308

  • Steen S, Ingemansson R, Eriksson L, Pierre L, Algotsson L, Wierup P, Liao Q, Eyjolfsson A, Gustafsson R, Sjoberg T. First human transplantation of a nonacceptable donor lung after reconditioning ex vivo. Ann Thorac Surg. 2007 Jun;83(6):2191-4. doi: 10.1016/j.athoracsur.2007.01.033.

    PubMed 17532422

  • Cypel M, Yeung JC, Liu M, Anraku M, Chen F, Karolak W, Sato M, Laratta J, Azad S, Madonik M, Chow CW, Chaparro C, Hutcheon M, Singer LG, Slutsky AS, Yasufuku K, de Perrot M, Pierre AF, Waddell TK, Keshavjee S. Normothermic ex vivo lung perfusion in clinical lung transplantation. N Engl J Med. 2011 Apr 14;364(15):1431-40. doi: 10.1056/NEJMoa1014597.

    PubMed 21488765

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ex vivo lung perfusion with Steen Solution™ in people with Lung Transplantation, run by XVIVO Perfusion at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. 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 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

PGD scores in the first 72 hours after lung transplantation. (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 NCT01190059, which also lists 9 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 4 Apr 2025.

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