Safety of prolonged preservation of lungs at 10°C compared to the standard of care: a multicenter prospective non-inferiority trial. In the presence of terminal lung diseases, a lung transplant is performed with the aim of prolonging patients' lives. Our research project aims to study whether the effectiveness presented by a lung preservation strategy at a temperature of 10°C between their retrieval and transplantation is at least equivalent to the traditional preservation method at 4°C. Lung transplantation is a well-controlled operation that represents the most effective treatment for certain lung diseases without other therapeutic alternatives. However, we still know little about the optimal conditions for preserving lungs between their retrieval and transplantation. We wish to evaluate whether their preservation at 10°C is at least equivalent to the current standard method (preservation at 4°C). Preservation of lungs at 4°C between their retrieval and transplantation currently represents the standard of care at CHUV.
Zusammenfassung der Studie
Lung transplantation is a well-controlled operation that represents the most effective treatment for certain lung diseases without therapeutic alternatives. However, we still know little about the optimal conditions for preserving lungs between their retrieval and transplantation. We wish to evaluate whether their preservation at 10°C is at least equivalent to the current standard method (preservation at 4°C). Participants in the project will be randomly assigned to a group intended to receive a transplant of lungs preserved at 4°C (control group) or preserved at 10°C. Preservation of lungs at 4°C between their retrieval and transplantation currently represents the standard of care at CHUV. This study will follow all lung transplant recipients for 12 months following the transplant. This is an international study for which we plan to include 300 participants in 12 centers of excellence in lung transplantation. This study is conducted in accordance with the provisions of Swiss legislation. We also follow all internationally recognized guidelines. The competent ethics committee, Swisstransplant, and the OFSP have reviewed and authorized the study. Procedure for participants Aside from the preservation temperature of the lungs that will be implanted, this study does not differ in any way from the normal course of a lung transplant as currently practiced at CHUV. Participants will, however, have the opportunity to be informed about the study, ask any necessary questions, and receive all necessary answers before making a decision. They will also be able to take the necessary time for reflection before deciding.
(BASEC)
Untersuchte Intervention
Lung transplantation is a well-controlled operation which represents the most effective treatment for certain lung diseases with no therapeutic alternative. However, we still know little about the optimal conditions for preserving lungs between their removal and their transplantation. We wish to evaluate whether their storage at 10°C is at least equivalent to the current standard method (storage at 4°C).
(BASEC)
Untersuchte Krankheit(en)
Terminal lung diseases requiring a transplant, with no other therapeutic alternative.
(BASEC)
Be between 18 and 80 years old Require a primary lung transplant Require bilateral lung transplant (BASEC)
Ausschlusskriterien
Require lung re-transplantation Require a multiple organ transplant (another organ in addition to the lungs) Require a unilateral lung transplant (BASEC)
Studienstandort
Lausanne, Zürich
(BASEC)
Sponsor
Prof. Dr. med Thorsten Krueger, CHUV, Lausanne
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Dr. med. Thorsten Krueger
+4121 314 2408
thorsten.krueger@clutterchuv.chCentre Hospitalier Universitaire Vaudois (CHUV)
(BASEC)
Allgemeine Auskünfte
University Health Network, Toronto,
416-340-4800
thorsten.krueger@clutterchuv.ch(ICTRP)
Allgemeine Auskünfte
University Health Network, Toronto
416-340-4800
thorsten.krueger@clutterchuv.ch(ICTRP)
Wissenschaftliche Auskünfte
University Health Network, Toronto,
416-340-4800
thorsten.krueger@clutterchuv.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Waadt
(BASEC)
Datum der Bewilligung durch die Ethikkommission
26.03.2024
(BASEC)
ICTRP Studien-ID
NCT05898776 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Safety of 10°C prolonged lung preservation vs. standard of care: a multi-centre prospective non-inferiority trial (BASEC)
Wissenschaftlicher Titel
Safety of 10C Lung Preservation vs. Standard of Care: A Multi-Centre Prospective Non-Inferiority Trial (ICTRP)
Öffentlicher Titel
10C vs 4C Lung Preservation RCT (ICTRP)
Untersuchte Krankheit(en)
Lung TransplantOrgan Preservation (ICTRP)
Untersuchte Intervention
Device: Lung transplantation after 10C donor lung preservationDevice: Lung transplantation after standard ice cooler donor lung preservation (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
Donor Inclusion Criteria
- Donation after brain death (DBD) or donation after cardiac death (DCD)
- Donor lungs are suitable to go straight to LTx (i.e., do not need ex vivo lung
perfusion (EVLP) assessment)
Donor Exclusion Criteria
- Concerns with organ preservation technique
- Need for EVLP assessment
Recipient Inclusion Criteria
- 18-80 years old
- Primary lung transplantation
- Bilateral lung transplantation
Recipient Exclusion Criteria
- Re-transplantation
- Multi-organ transplantation
- Single lung transplantation
- Participation in a contraindicating trial (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Incidence of Primary Graft Dysfunction (PGD) Grade 3 as per International Society for Heart and Lung Transplantation (ISHLT) (ICTRP)
Incidence of Primary Graft Dysfunction Grade 2-3 as per International Society for Heart and Lung Transplantation;Time on ventilator;Total ICU and hospital length of stay;Overall survival;Occurrence of acute rejection;Six minute walk test;Forced expiratory volume - one second (FEV1 in L) (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
Medical University of Vienna;Vanderbilt University;Puerta de Hierro University Hospital;University of California, San Francisco;Centre Hospitalier Universitaire Vaudois;Mayo Clinic;St Vincent's Hospital, Sydney;University of Texas Southwestern Medical Center;Spectrum Health Hospitals;University of Miami;University Hospital of Leuven Leuven;Centre hospitalier de l'Universit� de Montr�al (CHUM);University Hospital, Z�rich (ICTRP)
Weitere Kontakte
Elliot Wakeam, MD MPH;Sharaniyaa Balachandran, sharaniyaa.balachandran@uhn.ca, 416-340-4800, University Health Network, Toronto, (ICTRP)
Sekundäre IDs
22-5909 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT05898776 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar