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.
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
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)
Critères d'exclusion
Require lung re-transplantation Require a multiple organ transplant (another organ in addition to the lungs) Require a unilateral lung transplant (BASEC)
Lieu de l’étude
Lausanne, Zurich
(BASEC)
Sponsor
Prof. Dr. med Thorsten Krueger, CHUV, Lausanne
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Dr. med. Thorsten Krueger
+4121 314 2408
thorsten.krueger@clutterchuv.chCentre Hospitalier Universitaire Vaudois (CHUV)
(BASEC)
Informations générales
University Health Network, Toronto,
416-340-4800
thorsten.krueger@clutterchuv.ch(ICTRP)
Informations générales
University Health Network, Toronto
416-340-4800
thorsten.krueger@clutterchuv.ch(ICTRP)
Informations scientifiques
University Health Network, Toronto,
416-340-4800
thorsten.krueger@clutterchuv.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique du Vaud
(BASEC)
Date d'approbation du comité d'éthique
26.03.2024
(BASEC)
Identifiant de l'essai ICTRP
NCT05898776 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Safety of 10°C prolonged lung preservation vs. standard of care: a multi-centre prospective non-inferiority trial (BASEC)
Titre académique
Safety of 10C Lung Preservation vs. Standard of Care: A Multi-Centre Prospective Non-Inferiority Trial (ICTRP)
Titre public
10C vs 4C Lung Preservation RCT (ICTRP)
Maladie en cours d'investigation
Lung TransplantOrgan Preservation (ICTRP)
Intervention étudiée
Device: Lung transplantation after 10C donor lung preservationDevice: Lung transplantation after standard ice cooler donor lung preservation (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor). (ICTRP)
Critères d'inclusion/exclusion
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)
non disponible
Critères d'évaluation principaux et secondaires
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)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
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)
Contacts supplémentaires
Elliot Wakeam, MD MPH;Sharaniyaa Balachandran, sharaniyaa.balachandran@uhn.ca, 416-340-4800, University Health Network, Toronto, (ICTRP)
ID secondaires
22-5909 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT05898776 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible