- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02855372
Impact of the Age Difference Between the Donor and Recipient on the Morbidity and Mortality After Lung Transplantation. Study on a National Multicenter Cohort (COLT)
It is commonly accepted that the characteristics of the organ donor impact on the future post transplant. In lung transplantation (LP), the defining characteristics of the "ideal" donor includes an age less than 55 years. However, before the pulmonary graft shortage with a corresponding mortality still too high waiting list, the lung graft acceptance criteria were reassessed permitting criteria "extension" ( "marginal" graft). And were grafted, depending on the urgency and accessibility problems in the registry of potential candidate, organs from donors aged 55 and older with quite comparable to those obtained from younger donors . Nevertheless, it is common practice that the grafts from older donors are more readily allocated to older candidates and the most severe, as many confounding factors to assess the real impact of donor age on post-transplant evolution on small cohorts.
The main goal of this study is to compare the survival of lung transplant patients depending on the age difference between donor and recipient.
The study will be conducted from a broad national cohort of lung transplant patients registered in COLT ( Lung Transplantation COhort). Established in September 2009, promoted by the University Hospital of Nantes, COLT involves 11 lung transplant centers authorized on French territory. It provides a standardized common longitudinal monitoring of the recipient from his transplant. Currently more than 1,000 patients included in this study are transplanted.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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-
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Marseille Cedex 01, Frankrig, 13915
- Assistance Publique Hôpitaux de Marseille, Hôpital Nord
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Male or female adult patients, included in COLT cohort, thus having given a signed written consent
- Who received a lung transplant
Exclusion Criteria:
- Lung transplanted patients in a context of national priority
- Lung transplanted patients who died within 3 months after the surgery
- Patients for whom it is a second lung transplantation
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Lung transplanted patients
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Age difference in years between donor and recipient
Tidsramme: 1 day
|
The age difference will then be able to define two groups of patients:
|
1 day
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2015-39
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med Lungetransplantation
-
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-
Chinese Chronic Respiratory Disease Research NetworkRekruttering
-
Dokuz Eylul UniversityAfsluttetOne Lung VentilationKalkun
-
Seoul National University HospitalAfsluttet
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Seoul National University HospitalAfsluttet
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Yonsei UniversityAfsluttetOne Lung VentilationKorea, Republikken
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Sichuan UniversityWest China HospitalMidlertidigt ikke tilgængeligOne Lung Ventilation
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Joseph D. TobiasAfsluttetOne-lung Ventilation (OLV)Forenede Stater
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University Health Network, TorontoAktiv, ikke rekrutterende
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Papa Giovanni XXIII HospitalAfsluttetLungetransplantation | Ex Vivo Lung PerfusionItalien
Kliniske forsøg med Lung transplantation
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Pharus Taiwan, Inc.Rekruttering
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AidenceRekruttering
-
TaiHao Medical Inc.Aktiv, ikke rekrutterende
-
London Health Sciences CentreUkendt
-
Inonu UniversityAfsluttetRygning | Iltmangel
-
KU LeuvenUkendtLungebetændelse, viral | Lungebetændelse | Graviditetsrelateret | Graviditet, høj risiko | COVID | Diagnostiserer sygdom | Graviditetskomplikationer, smitsom | GraviditetssygdomBelgien, Italien, Det Forenede Kongerige
-
Southern Illinois UniversityAmerican Lung AssociationAfsluttet
-
contextflow GmbHAfsluttet
-
Navigation Sciences, Inc.Aktiv, ikke rekrutterende