기증자 폐의 보존 개선을 위한 글로벌 활용 및 레지스트리 데이터베이스 (GUARDIANLUNG)
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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
-
-
Arizona
-
Phoenix, Arizona, 미국, 85013
- St. Joseph's Hospital and Medical Center
-
-
California
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San Francisco, California, 미국, 94143
- University of California, San Francisco
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Stanford, California, 미국, 94305
- Stanford Medicine
-
-
Florida
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Jacksonville, Florida, 미국, 32224
- Mayo Clinic Jacksonville
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-
Maryland
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Baltimore, Maryland, 미국, 21218
- Johns Hopkins University
-
-
Massachusetts
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Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital
-
-
New York
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The Bronx, New York, 미국, 10467
- Montefiore Hospital
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-
North Carolina
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Durham, North Carolina, 미국, 27710
- Duke Lung Transplant Clinic
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-
Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19140
- Temple University Hospital
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Pittsburgh, Pennsylvania, 미국, 15213
- University of Pittsburgh Medical Center
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-
Texas
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Dallas, Texas, 미국, 75246
- Baylor Scott & White Research Institute
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Dallas, Texas, 미국, 75390
- The University of Texas Southwestern Medical Center
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Houston, Texas, 미국, 77030
- Houston Methodist Hospital
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Virginia
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Charlottesville, Virginia, 미국, 22908
- University of Virginia
-
-
-
-
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Leuven, 벨기에, 3000
- University Hospitals Leuven
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Primary lung transplant candidates at centers that use the LungGuard device
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: CROSS_SECTIONAL
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of subjects with Primary Graft Dysfunction (PGD)
기간: 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
기간: Post-transplant through 5 years post
|
Subjects that show signs to rejection after transplant |
Post-transplant through 5 years post
|
|
Survival
기간: Post-transplant through 5 years post
|
patient survival post-transplant |
Post-transplant through 5 years post
|
|
ICU Length of Stay
기간: Transplant through 5 years post-transplant
|
Days the subject spent the ICU post-transplant |
Transplant through 5 years post-transplant
|
|
Hospital Length of Stay
기간: Transplant through 5 years post-transplant
|
Days the subject was in the hospital in total after transplant |
Transplant through 5 years post-transplant
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of rehospitalizations
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Matthew Hartwig, MD, Duke University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- PGX-004
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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