Unique ID issued by UMIN | UMIN000038181 |
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Receipt number | R000043379 |
Scientific Title | The efficacy and safety of machine perfusion preservation for marginal kidney graft |
Date of disclosure of the study information | 2020/04/01 |
Last modified on | 2023/10/31 16:49:49 |
The efficacy and safety of machine perfusion preservation for marginal kidney
The efficacy and safety of machine perfusion preservation for marginal kidney graft
The efficacy and safety of machine perfusion preservation for marginal kidney graft
The efficacy and safety of machine perfusion preservation for marginal kidney graft
Japan |
End stage renal disease
Surgery in general |
Others
NO
The safety and efficacy of machine perfusion preservation for marginal kidney transplantation grafts
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Major endopoints
The stability of flow, perfusion pressure and temparature during perfusion preservation for two hours
Post op. HD days, Frequency of required post op HD
Post op Cr(mg/dl)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Diagnosis
Device,equipment |
Kidney for transplantation procured from marginal donor graft is preserved by machine perfusion system.
Kidney is preserved after procurement by simple storage in donor hospital ,then, transfered and perfused for 2 hours in a hypothermic state under 30mmHg of renal arterial pressure in recipient hosipital
.Perfusion time will be at least 2 hours
15 | years-old | <= |
70 | years-old | >= |
Male and Female
kidney graft is selected by Japanese Organ Transolant Network
Among kidney graft,
marginal donor graft is used for this study under the criteria of United Nation Organ Sharing in USA
1)Donor age morethan 60Y/O
2)Donor age morethan 50y/o and death b cerebro-cardiavascular disease, hypertension or serum Cr more than 1.5 mg/dl
3) Death after cardiac death donor
Exclusion criteria
1;Disease
1) Severe heart, liver disease
2) Active infection
3) Malignant disease
4) Others by professional judgement by Medical Dr
2) Female; Pregnant male; having baby until 3 months after transplantation
3) Under 18 Y/oat the time of transplantation
4) Simutaneous pancreas and kidney transplantation
15
1st name | Naoto |
Middle name | |
Last name | Matsuno |
Asahikawa Medical University
Hepato-Biliary- Pancreas surgery & Transplantation
078-8510
Midorigaoka Higashi 2-1, Asahikawa, Hokkaido, Japan
0166-68-2508
mtn@asahikawa-med.ac.jp
1st name | Naoto |
Middle name | |
Last name | Matsuno |
Asahikawa Medical Unievrsity
Hepato-Biliary- Pancreas surgery & Transplantation
078-8510
Midorigaoka Higashi 2-1, Asahikawa, Hokkaido, Japan
0166(68)2508
mtn@ashiakwa-med.ac.jp
Asahikawa Medical University
Self fiunding
Self funding
Tokyo medical university hachioji medical center
Toranomon hospital
Tohoku university
Fujita health university
Asahikawa medical university
Asahikawa Medical University
Midorigaoka Higashi 2-1, Asahikawa , HOkkaido,
0166-68-2508
mtn@asahikawa-med.ac.jp
NO
東京医科大学八王子医療センター(東京都)、虎の門病院(東京都)、東北大学病院(宮城県)、藤田医科大学病院(愛知県)、旭川医科大学病院(北海道)
2020 | Year | 04 | Month | 01 | Day |
Partially published
13
16 cases of diseased kidney transplantation were peformed after machine perfusion preservation.
Donor age;21~65y/o. Recopient age: 37~66y/o. Donor Cr before procurement: 0.47~4.1mg/dl Machine eprfusion time: 85~250min.
All kidney was perfused without any troubles, and not required post.op HD until discharge.
2021 | Year | 03 | Month | 03 | Day |
2021 | Year | 03 | Month | 18 | Day |
Donor age54~65 y/o
Recipient age; 47~66 y/o
Years of pre.op HD: 13~24
DCD
(Donation after cardiac death); 4 cases
Warm isdhemic time :0~18 min.
total ischemic time 7:10~15;27
ascites 1 case.
No trouble related with machine perfusion preservation
Renal function after transplantation
Days required HD; 0 day om 3cases, 8 days in 1 case, 18 days in 1 case
All cases was no HD at the time of
discharge.
Best Cr after transplantation were 1,71,1,60,1,19,1,10,1,81(mg/dl) in each case.
Yes
Original article
Y Nakamura et al Transplantation proc.2021
S Miyagi et al : Ishoku (in Japanes) 20211
Japan Society for clinical renal tarsnplantation Sep/2021
Japanese society for Organ Transplantation, Machine perfusion meeting ( Sep/2021)
Japanese Society for Organ preservation and Biology2021 Key Note (Nov.2021)
Spring Seminar , Japanese Society for organ transplantation (March/2022
H.Iwamoto et al;Japanese scoety ofr organ transplantation 2022
Open public recruiting
2019 | Year | 11 | Month | 01 | Day |
2020 | Year | 09 | Month | 10 | Day |
2020 | Year | 04 | Month | 01 | Day |
2024 | Year | 03 | Month | 31 | Day |
2024 | Year | 03 | Month | 31 | Day |
2024 | Year | 03 | Month | 31 | Day |
2025 | Year | 06 | Month | 30 | Day |
2019 | Year | 10 | Month | 02 | Day |
2023 | Year | 10 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043379
Research Plan | |
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Registered date | File name |
2021/04/13 | 研究計画書 20190912.docx |
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Research case data | |
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