Image Transmission Applied to Organ Transplant: Before-after Study of the Effectiveness of the Device
Image Transmission Applied to Organ Transplant: Before-after Study of the Device of the Effectiveness
In the complex process of organ transplant, two of the major steps are:
- evaluation of the organs of potential donors in health institutions:
- proposing grafts to the transplant teams, according to rules defined at the national level.
In the absence of the possibility of transmitting the images between the deceased donor sites and the transplant teams, the visualization of these examinations does not take part in the decision-making of the transplant team. This leads in the displacement of the transplant team in order to verify the grafts after acceptance of the graft proposal.
The "Cristal Image" project is a visualisation project for the transplant teams, in real time, at the time of the proposal of the graft so that they can give an opinion (acceptance, refusal) in less than 20 minutes (legal delay for a vital organ) after analyzing the medical records provided and the imaging data (scanner, ultrasound (s), coronary angiography, etc.).
The hypothesis of the project is that the implementation of a secure image transmission (complete anonymisation of the data of the donor) before the acceptance by the team, will allow an optimization of the use of the qualified organs by reducing risks, unnecessary displacement of transplant surgical teams, and securing the allocation of organs to recipient patients.
調査の概要
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
-
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Saint-Denis、フランス、93200
- 募集
- Agence de la biomédecine
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コンタクト:
- Hélène Logerot, MD
- メール:helene.logerot@biomedecine.fr
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主任研究者:
- Hélène Logerot, MD
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主任研究者:
- Huot Olivier, MD
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副調査官:
- Laouabdia Karim, MD
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副調査官:
- Bastien Olivier, MD, PhD
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副調査官:
- Legeai Camille, MD
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副調査官:
- Lucas-Samuel Samuel, MD
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-
参加基準
適格基準
就学可能な年齢
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
説明
Inclusion Criteria:
- French Donors who died in brain death, at least one organ of which was proposed for transplantation (kidneys, liver, heart, lung); Recipients transplanted during the same periods.
Exclusion Criteria:
- Donors who died after cardiac arrest
- Donors taken care in a foreign country or outside the Metropolitan France
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
コホートと介入
グループ/コホート |
介入・治療 |
---|---|
Group without image transmission
"Before" Group
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Group with image transmission
"After" Group
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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 |
時間枠 |
---|---|
Number of successful organ transplantation among those sampled.
時間枠:3 months after transplantation for kidney, 1 year after transplantation for the other organs
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3 months after transplantation for kidney, 1 year after transplantation for the other organs
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二次結果の測定
結果測定 |
時間枠 |
---|---|
Number of assigned organs but not sampled
時間枠:Immediately after the decision of the transplant team
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Immediately after the decision of the transplant team
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Number of useless graft transportation
時間枠:Immediately after the decision of the transplant team
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Immediately after the decision of the transplant team
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Number of useless graft team transportation
時間枠:Immediately after the decision of the transplant team
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Immediately after the decision of the transplant team
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Mortality or function stop
時間枠:1 year after transplantation
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1 year after transplantation
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Duration of the graft assignment
時間枠:Immediately after graft assignment
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Immediately after graft assignment
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Cost of sampling process
時間枠:Immediately after the sampling process
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Immediately after the sampling process
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Use of image transmission by the graft team
時間枠:Immediately after decision of the transplant team to accept or not the graft
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Immediately after decision of the transplant team to accept or not the graft
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協力者と研究者
捜査官
- 主任研究者:Isabelle Durand-Zaleski, MD, PhD、Assistance Publique - Hôpitaux de Paris - DRCD URC Eco
出版物と役立つリンク
一般刊行物
- Reddy MS, Bhati C, Neil D, Mirza DF, Manas DM. National Organ Retrieval Imaging System: results of the pilot study. Transpl Int. 2008 Nov;21(11):1036-44. doi: 10.1111/j.1432-2277.2008.00720.x.
- Rosenkrantz AB, Campbell N, Wehrli N, Triolo MJ, Kim S. New OPTN/UNOS classification system for nodules in cirrhotic livers detected with MR imaging: effect on hepatocellular carcinoma detection and transplantation allocation. Radiology. 2015 Feb;274(2):426-33. doi: 10.1148/radiol.14140069. Epub 2014 Oct 7.
- Furlow B. Solid organ donation and transplantation. Radiol Technol. 2012 Mar-Apr;83(4):371-89. Erratum In: Radiol Technol. 2012 May-Jun;83(5):446.
- Fregeville A, De Bazelaire C, Zagdanski A, Albiter M, Desgrandchamps F, De Kerviler E. [Value of whole body CTA in the management of brain-dead patients]. J Radiol. 2010 Jan;91(1 Pt 1):37-44. doi: 10.1016/s0221-0363(10)70004-4. French.
- Charrier N, Zarca K, Durand-Zaleski I, Calinaud C; ARS Ile de France telemedicine group. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res. 2016 Feb 8;16:45. doi: 10.1186/s12913-016-1281-1.
- Zarca K, Dupont JK, Jacoud L, Bulsei J, Huot O, Logerot H, Durand-Zaleski I. Effectiveness and efficiency of teleimaging in the transplantation process: a mixed method protocol. BMC Health Serv Res. 2019 Sep 18;19(1):672. doi: 10.1186/s12913-019-4488-0.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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
その他の研究ID番号
- PREPS - Cristal Images
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
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。
"After" Groupの臨床試験
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Johns Hopkins UniversityNational Institute on Aging (NIA)募集
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University Hospital, GhentUniversity Ghent募集
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Centre hospitalier de l'Université de Montréal...University Health Network, Toronto; University of British Columbia; McGill University; University... と他の協力者募集
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University of HawaiiNational Institute on Minority Health and Health Disparities (NIMHD)完了
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Kocaeli Derince Education and Research HospitalKocaeli Universityわからない
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Northeast Center for Rehabilitation and Brain InjuryProbed Medical USAわからない
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Amsterdam UMC, location VUmcRed Cross Hospital Beverwijk完了