Global udnyttelses- og registerdatabase for forbedret bevaring af donor-lunger (GUARDIANLUNG)
Global udnyttelses- og registerdatabase til forbedret bevaring af donorlunger
The objective of this registry is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor lung that were preserved and transported within the LUNGguard system, as well as retrospective standard of care patients
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
GUARDIAN-Lung is a post-market, observational registry of adult and pediatric lung transplant recipient patients whose donor lungs was preserved and transported within the LUNGguard. The data is being collected retrospectively from medical records of patients already transplanted before the initiation of the registry and any new patients who meet the eligibility criteria.
About 3,500 male and female subjects (including pediatric patients) meeting the study inclusion and exclusion criteria will be enrolled into the study at about 25 clinical sites.
Candidates that fit the eligibility criteria and have had their donor lungs transported with a Paragonix product or a standard of care method can be enrolled. The baseline characteristics and outcomes of the two groups will be compared.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiesteder
-
-
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Leuven, Belgien, 3000
- University Hospitals Leuven
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-
-
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Arizona
-
Phoenix, Arizona, Forenede Stater, 85013
- St. Joseph's Hospital and Medical Center
-
-
California
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San Francisco, California, Forenede Stater, 94143
- University of California, San Francisco
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Stanford, California, Forenede Stater, 94305
- Stanford Medicine
-
-
Florida
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Jacksonville, Florida, Forenede Stater, 32224
- Mayo Clinic Jacksonville
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21218
- Johns Hopkins University
-
-
Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
-
-
New York
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The Bronx, New York, Forenede Stater, 10467
- Montefiore Hospital
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-
North Carolina
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Durham, North Carolina, Forenede Stater, 27710
- Duke Lung Transplant Clinic
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-
Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19140
- Temple University Hospital
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- University of Pittsburgh Medical Center
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-
Texas
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Dallas, Texas, Forenede Stater, 75246
- Baylor Scott & White Research Institute
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Dallas, Texas, Forenede Stater, 75390
- The University of Texas Southwestern Medical Center
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Houston, Texas, Forenede Stater, 77030
- Houston Methodist Hospital
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22908
- University of Virginia
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Primary lung transplant candidates at centers that use the LungGuard device
Beskrivelse
Inclusion Criteria:
- Donor and donor lungs matched to the prospective recipient based upon institutional medical practice
- Registered male or female primary lung transplant candidates including pediatric candidates
Exclusion Criteria:
- Donor and donor lungs that do not meet institutional clinical requirements for transplantation
- Patients who are incarcerated persons (prisoners)
- Patients who have had a previous major organ transplant (heart, lungs, liver, kidney, pancreas)
- Patients who are receiving multiple organ transplants
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: CROSS_SECTIONAL
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
LungGuard patients
Patients whose donor lung(s) was transported with the LungGuard device. |
The LUNGguard is an FDA cleared and is a CE-marked medical device intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs. The intended organ storage time for the LUNGguard is up to 8 hours. |
|
Standard Transport Patients
Patients whose donor lung(s) was transported with a method other than the LungGuard |
|
|
BAROGuard Patients
Patients whose donor lung(s) was transported with the BAROGuard device. |
The BAROguard (the "System") is ultraportable hypothermic preservation and transport system intended for use with donor lungs. BAROguard is a legally marketed, FDA cleared medical device in the United States. The intended organ storage time for BAROguard™ is up to 8 hours. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of subjects with Primary Graft Dysfunction (PGD)
Tidsramme: Post-transplant through 5 years post
|
The number of subjects that develop PGD after transplant |
Post-transplant through 5 years post
|
|
Number of subjects with rejection
Tidsramme: Post-transplant through 5 years post
|
Subjects that show signs to rejection after transplant |
Post-transplant through 5 years post
|
|
Survival
Tidsramme: Post-transplant through 5 years post
|
patient survival post-transplant |
Post-transplant through 5 years post
|
|
ICU Length of Stay
Tidsramme: Transplant through 5 years post-transplant
|
Days the subject spent the ICU post-transplant |
Transplant through 5 years post-transplant
|
|
Hospital Length of Stay
Tidsramme: Transplant through 5 years post-transplant
|
Days the subject was in the hospital in total after transplant |
Transplant through 5 years post-transplant
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of rehospitalizations
Tidsramme: post-transplant through 1 year
|
The number of times the subject was readmitted to the hospital after discharged post-transplant |
post-transplant through 1 year
|
|
How long subjects needed mechanical support
Tidsramme: pre-transplant through 48 hours post-transplant
|
Amount of time (minutes) mechanical support (EMCO and ventilator) was needed pre and post transplant |
pre-transplant through 48 hours post-transplant
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Matthew Hartwig, MD, Duke University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Kronisk sygdom
- Sygdomsegenskaber
- Genetiske sygdomme, medfødte
- Luftvejssygdomme
- Sygdomme i fordøjelsessystemet
- Lungesygdomme
- Spædbarn, Nyfødt, Sygdomme
- Lungesygdomme, obstruktiv
- Pancreassygdomme
- Fibrose
- Hypertension, lunge
- Medfødte, arvelige og neonatale sygdomme og abnormiteter
- Patologiske tilstande, tegn og symptomer
- Pulmonal arteriel hypertension
- Lungesygdom, kronisk obstruktiv
- Lungefibrose
- Lungesygdomme, interstitielle
- Emfysem
- Cystisk fibrose
Andre undersøgelses-id-numre
- PGX-004
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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