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Lung TransplantADRTPNCT05195853

Optimization of Donor-Recipient Matching in Lung Transplantation

An observational study of Lung Transplant, run by Fondation Hôpital Saint-Joseph at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Lung transplantation is the curative treatment for end-stage respiratory failure involving highly selected patients. In 2018, the International Transplant Registry counts 69200 lung transplants among 260 transplant centers. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Transplant
How many people
500 participants
Where
1 siteFrance
Study dates
15 Jan 2022to 31 Dec 2023
Phase
Observational
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

Study population: These patients were admitted for a bi-lung transplant performed by the Marie Lannelongue lung transplant team between January 1, 2007 and April 30, 2021.

Who may be able to join

  • Patients who have received a bi-lung transplant performed by the Marie Lannelongue lung transplant team between January 1, 2007 and April 30, 2021 All indications for transplantation will be considered, including retransplantation.
  • French-speaking patient

Who cannot join

  • Patient is a minor (<18 years old) at the time of transplantation
  • Patient's refusal to participate in the study
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Patient objecting to the use of his/her data for this research

Trial locations and contacts

1 site in 1 country.

Anne Buronfosse, MD contact

144123873 ext. +33

aburonfosse@ghpsj.fr

Helene BEAUSSIER, PharmD, PhD contact

0144127883 ext. +33

crc@ghpsj.fr

France1 site, 1 recruiting

  • Groupe Hospitalier Paris Saint-Joseph

    Paris, 75014

    Anne Buronfosse, MD

    Recruiting

Other trials in France

About this study

Lung transplantation is the curative treatment for end-stage respiratory failure involving highly selected patients. In 2018, the International Transplant Registry counts 69200 lung transplants among 260 transplant centers. Between 2010 and June 2017, the 3-month survival rate of patients after lung transplantation is 90%. The causes of early death are primary graft failure, renal failure, infections, acute rejection (cellular or humoral), surgical complications. The median survival is 6.7 years and the median conditioned survival at 1 year is 8.9 years. Bronchiolitis obliterans is the leading cause of death after 1 year; it affects 10% more patients each year and peaks at 5 years at more than 50% of transplanted patients. These results encourage transplant professionals to continue their efforts to improve the prognosis of transplantation. Among these, the optimization of graft matching, taking into account the characteristics of the donor and the recipient, constitute a relevant avenue of study. Several donor characteristics seem to play a role in the prognosis of the transplant. Survival at 12 months is significantly worse when the donor's age is greater than 50 years. There does not appear to be a significant difference in donor cause of death. Recipients of a graft exposed to smoking ≥ 20 pack-years have a 3% and 1.5% decreased survival at 1 and 5 years postoperatively.

Similarly, the 5-year survival of patients with conditional 1-year survival is poorer in case of other toxic exposures such as alcohol, cocaine, crack or marijuana. Analysis of international registry data also suggests a negative association between post-transplant survival and donor hypertension and diabetes. However, the biological mechanisms by which these factors affect survival remain unknown. Graft ischemia time is significantly associated with survival with a 5-year survival of 70% and 65% for grafts exposed to ischemia ≥ 4 hours or less. The cumulative effect of donor hypertension and ischemia time are appreciated by the fact that the best postoperative survival is observed in donors without hypertension and graft ischemia time ≥ 4 hours. Graft size is also associated with post-transplant prognosis, in front of a significant decrease in survival for patients with emphysema, chronic obstructive pulmonary disease, alpha-1 antitrypsin deficiency, transplanted with a smaller graft size.

This result is not found in patients transplanted for pulmonary fibrosis. One study has also suggested the negative role of a gender mismatch between donor and recipient on post-transplant survival, but there is currently no clear explanation for this result. The presence of antibodies to the recipient's HLA system [DSA (donor-specific antibodies)] in pre-transplant is a risk factor for hyperacute rejection and chronic graft dysfunction. Thus, the choice of matching between the donor and the recipient appears complex in view of the number of criteria to be taken into account which impact the duration of post-transplant survival in the short and medium term. The objective of the project is to develop a decision support tool, using artificial intelligence algorithms, to assist the thoracic surgeon in identifying the patient, among those registered on the team's waiting list, who could benefit most from a bi-pulmonary graft offered by the Biomedicine Agency.

Conditions
Lung Transplant

What is being measured

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

  1. Construction of a tool to predict 90-day survival of patients managed for bi-pulmonary transplantation

    This outcome corresponds to the number of all-cause deaths within 90 days of transplantation. Deaths occurring during hospitalization or at home are taken into account

    Measured: Day 90

Secondary outcomes (4)

  1. Prediction of the risk of a complication during the transplant hospital stay

    This outcome corresponds to the occurrence of complications during the transplantation hospital stay leading to an increase in the length of hospitalization.

    Measured: Day 90

  2. Number of hospitalization at Year 1

    This outcome corresponds to the number of hospitalization during the first year.

    Measured: Year 1

  3. Number of rejection of the transplant at Year 1

    This outcome corresponds to the rejection of the transplant during the first year.

    Measured: Year 1

  4. Respiratory functional benefit in the year following transplantation

    This outcome corresponds to the functional benefit in terms of respiratory function. This criterion will be assessed on the basis of the results of the EFR performed during the first year post-transplant. The criterion will be the difference between the first post-transplant FEV1 and the best FEV1 obtained during the year under consideration.

    Measured: Year 1

Timeline

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

  1. First posted19 Jan 2022
  2. Study start15 Jan 2022
  3. Primary completion15 Nov 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05195853
Sponsor's protocol ID
ADRTP
Acronym
ADRTP
Status last verified
Dec 2022
First submitted
31 Dec 2021
Last updated
30 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Leard LE, Holm AM, Valapour M, Glanville AR, Attawar S, Aversa M, Campos SV, Christon LM, Cypel M, Dellgren G, Hartwig MG, Kapnadak SG, Kolaitis NA, Kotloff RM, Patterson CM, Shlobin OA, Smith PJ, Sole A, Solomon M, Weill D, Wijsenbeek MS, Willemse BWM, Arcasoy SM, Ramos KJ. Consensus document for the selection of lung transplant candidates: An update from the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2021 Nov;40(11):1349-1379. doi: 10.1016/j.healun.2021.07.005. Epub 2021 Jul 24.

    PubMed 34419372

  • Chambers DC, Cherikh WS, Harhay MO, Hayes D Jr, Hsich E, Khush KK, Meiser B, Potena L, Rossano JW, Toll AE, Singh TP, Sadavarte A, Zuckermann A, Stehlik J; International Society for Heart and Lung Transplantation. The International Thoracic Organ Transplant Registry of the International Society for Heart and Lung Transplantation: Thirty-sixth adult lung and heart-lung transplantation Report-2019; Focus theme: Donor and recipient size match. J Heart Lung Transplant. 2019 Oct;38(10):1042-1055. doi: 10.1016/j.healun.2019.08.001. Epub 2019 Aug 8. No abstract available.

    PubMed 31548030

  • Chambers DC, Zuckermann A, Cherikh WS, Harhay MO, Hayes D Jr, Hsich E, Khush KK, Potena L, Sadavarte A, Singh TP, Stehlik J; International Society for Heart and Lung Transplantation. The International Thoracic Organ Transplant Registry of the International Society for Heart and Lung Transplantation: 37th adult lung transplantation report - 2020; focus on deceased donor characteristics. J Heart Lung Transplant. 2020 Oct;39(10):1016-1027. doi: 10.1016/j.healun.2020.07.009. Epub 2020 Jul 30. No abstract available.

    PubMed 32782073

  • Demir A, Coosemans W, Decaluwe H, De Leyn P, Nafteux P, Van Veer H, Verleden GM, Van Raemdonck D. Donor-recipient matching in lung transplantation: which variables are important?dagger. Eur J Cardiothorac Surg. 2015 Jun;47(6):974-83. doi: 10.1093/ejcts/ezu340. Epub 2014 Sep 3.

    PubMed 25187532

  • Frost AE, Jammal CT, Cagle PT. Hyperacute rejection following lung transplantation. Chest. 1996 Aug;110(2):559-62. doi: 10.1378/chest.110.2.559.

    PubMed 8697867

  • Brugiere O, Suberbielle C, Thabut G, Lhuillier E, Dauriat G, Metivier AC, Gautreau C, Charron D, Mal H, Parquin F, Stern M. Lung transplantation in patients with pretransplantation donor-specific antibodies detected by Luminex assay. Transplantation. 2013 Mar 15;95(5):761-5. doi: 10.1097/TP.0b013e31827afb0f.

    PubMed 23296148

  • Snell GI, Yusen RD, Weill D, Strueber M, Garrity E, Reed A, Pelaez A, Whelan TP, Perch M, Bag R, Budev M, Corris PA, Crespo MM, Witt C, Cantu E, Christie JD. Report of the ISHLT Working Group on Primary Lung Graft Dysfunction, part I: Definition and grading-A 2016 Consensus Group statement of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2017 Oct;36(10):1097-1103. doi: 10.1016/j.healun.2017.07.021. Epub 2017 Jul 26. No abstract available.

    PubMed 28942784

  • Seely AJ, Ivanovic J, Threader J, Al-Hussaini A, Al-Shehab D, Ramsay T, Gilbert S, Maziak DE, Shamji FM, Sundaresan RS. Systematic classification of morbidity and mortality after thoracic surgery. Ann Thorac Surg. 2010 Sep;90(3):936-42; discussion 942. doi: 10.1016/j.athoracsur.2010.05.014.

    PubMed 20732521

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Transplant, run by Fondation Hôpital Saint-Joseph at 1 site in France.

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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 30 Dec 2022. 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 France. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anne Buronfosse, MD (144123873 ext. +33, aburonfosse@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Construction of a tool to predict 90-day survival of patients managed for bi-pulmonary transplantation (time frame: Day 90). 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 NCT05195853, which also lists 8 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 30 Dec 2022.

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