ドナー肺の保存を改善するためのグローバル利用および登録データベース (GUARDIANLUNG)
ドナー肺の保存を改善するためのグローバルな利用と登録データベース
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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究場所
-
-
Arizona
-
Phoenix、Arizona、アメリカ、85013
- St. Joseph's Hospital and Medical Center
-
-
California
-
San Francisco、California、アメリカ、94143
- University of California, San Francisco
-
Stanford、California、アメリカ、94305
- Stanford Medicine
-
-
Florida
-
Jacksonville、Florida、アメリカ、32224
- Mayo Clinic Jacksonville
-
-
Maryland
-
Baltimore、Maryland、アメリカ、21218
- Johns Hopkins University
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
-
-
New York
-
The Bronx、New York、アメリカ、10467
- Montefiore Hospital
-
-
North Carolina
-
Durham、North Carolina、アメリカ、27710
- Duke Lung Transplant Clinic
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、アメリカ、19140
- Temple University Hospital
-
Pittsburgh、Pennsylvania、アメリカ、15213
- University of Pittsburgh Medical Center
-
-
Texas
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Dallas、Texas、アメリカ、75246
- Baylor Scott & White Research Institute
-
Dallas、Texas、アメリカ、75390
- The University of Texas Southwestern Medical Center
-
Houston、Texas、アメリカ、77030
- Houston Methodist Hospital
-
-
Virginia
-
Charlottesville、Virginia、アメリカ、22908
- University of Virginia
-
-
-
-
-
Leuven、ベルギー、3000
- University Hospitals Leuven
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Primary lung transplant candidates at centers that use the LungGuard device
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：CROSS_SECTIONAL
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of subjects with Primary Graft Dysfunction (PGD)
時間枠：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
時間枠：Post-transplant through 5 years post
|
Subjects that show signs to rejection after transplant |
Post-transplant through 5 years post
|
|
Survival
時間枠：Post-transplant through 5 years post
|
patient survival post-transplant |
Post-transplant through 5 years post
|
|
ICU Length of Stay
時間枠：Transplant through 5 years post-transplant
|
Days the subject spent the ICU post-transplant |
Transplant through 5 years post-transplant
|
|
Hospital Length of Stay
時間枠：Transplant through 5 years post-transplant
|
Days the subject was in the hospital in total after transplant |
Transplant through 5 years post-transplant
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of rehospitalizations
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Matthew Hartwig, MD、Duke University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- PGX-004
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。