The INSPIRE International Lung Trial with the Organ Care System Technology (OCS™) - Interim Report
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Le résumé fourni par la source
Objectives: To assess the clinical efficacy and safety of the OCS™ device to preserve, recruit and assess donor lungs for transplantation as compared with the current cold storage technique. Methods: INSPIRE is a prospective, international, multi-centered, randomized, controlled trial comparing preservation of donor lungs using OCS-Lung perfusion device (OCS Group) to cold flush and storage (Control Group). A total of 350 primary lung transplant recipients will be randomized into the trial. Important donor inclusion criteria: age < 65, normal gas exchange at time of final acceptance. Important recipient inclusion criteria: age ≥ 18 years old. Donor exclusion criteria: positive serology; presence of traumatic lung injury; presence of confirmed active pneumonia. Important recipient exclusion criteria: prior transplant; single lung recipient and multi-organ transplant recipient. Primary study endpoint is a composite of patient and graft survival at day 30 post transplantation, and incidence of ISHLT primary graft dysfunction (PGD) Grade 3 post-transplantation. Other endpoints: PGD scores at T0, T24, and T48 hours; duration of invasive mechanical ventilation; length of post transplant ICU stay; length of post-transplant hospital stay; additional hospital admission post initial discharge. Results: As of July 30 th , 2014, a total of 316 patients were recruited and transplanted in the INSPIRE Trial in 21 different centres in Europe, North America and Australia. We are reporting on the first 245 per-protocol patients having completed the 30-day follow-up endpoint as of March 1 st , 2014, including n = 111 OCS & n = 134 Control subjects. Most donor and recipient characteristics/risk factors were equivalent in both groups. Median pre-transplant lung allocation score was 44 in the OCS and 38 in the Control group. Patient hospital survival was 96% in the OCS and 95% in the Control group and at 6 months, it was OCS =90% versus Control =89%. The incidence of PGD Grade 3 was lower in the OCS group. PGD grade 3 OCS group ( n = 111) Control group ( n = 134) PGD grade 3. T-0 14% 22% T-24 10% 12% T-48 5% 5% T-72 3% 5% Conclusion: The INSPIRE Trial's interim results are encouraging as it is demonstrating a trend toward reduction of PGD grade 3 post-lung transplantation. INSPIRE accrual is expanding and we expect completion of the trial by end of 2014.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- The INSPIRE International Lung Trial with the Organ Care System Technology (OCS™) - Interim Report
- Date Crossref
- 20/01/2015
- Éditeur
- Georg Thieme Verlag KG
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Medizinische Hochschule Hannover pays non établi dans la noticeUniversité ou école supérieure
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University of Minnesota System pays non établi dans la noticeUniversité ou école supérieure
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St. Joseph's Hospital and Medical Center pays non établi dans la noticeÉtablissement de santé
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Hôpital Civil pays non établi dans la noticeÉtablissement de santé
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University of Padua pays non établi dans la noticeUniversité ou école supérieure
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Medizinische Hochschule Hannover, University of Minnesota System et St. Joseph's Hospital and Medical Center, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.