Prediction and Management of Delayed Graft Function Based on Donor Criteria and LifePort Platform
NCT ID: NCT02876692
Last Updated: 2016-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1000 participants
OBSERVATIONAL
2016-01-31
2019-12-31
Brief Summary
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1. First step: to establish a new scoring system for predication of delayed graft function(DGF) following kidney transplantation based on previous and new study data. The new scoring system is comprised of two parts: Xi'an Criteria of donor scoring system and kidney evaluation System based on Lifeport platform ).
2. Second step: validate the new scoring system through prospective cohort study in our transplantation center and modify the scoring system if needed. Recruiting 300 patients, follow up at day 3, week 1, month 1, month 3, month 6 and month 12. Patients will be followed for Cr30cl, DGF,primary non-function (PNF), acute rejection (AR), graft survival and patient survival
3. Step 3: Further validate the new scoring system in six other transplantation centers and developing a software in the end. Recruiting 300 patients, follow up at day 3, week 1, month 1, month 3, month 6 and month 12. Patients will be followed for Cr30cl, DGF, PGF, AR, graft survival and patient survival
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Machine perfusion
Deceased donor kidneys were preserved by hypothermic machine perfusion
Eligibility Criteria
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Inclusion Criteria
* 1\. Comply with the national donation after citizen death guideline
* 2\. No high risk activities: such as history of drug abuse, history of intravenous drug use and risky sexual behavior
* 3\. No malignant melanoma, metastatic cancer, or incurable cancer; some of the early stages of cancer after a successful treatment can also be considered
* 4\. No activity of untreated systemic bacterial, viral or fungal infection;
* 5\. Patients definitely identified
Recipient:
* 1\. 65 y old ≥Age\> = 18 years old, male or female
* 2\. BMI\<26
* 3\. Renal transplantation first time
* 4\. Not in pregnancy or lactation, pregnancy test was negative, and promise not to be pregnant during treatment.
* 5\. Before the clinical trial, Patient sign informed consent voluntarily
Exclusion Criteria
* 1\. Older than 65 years old
* 2.Serum hepatitis B virus (HBV), hepatitis C virus (HCV), HIV positive
* 3.Donor kidney cold storage time over 30 hours
* 4.Warm ischemia time over 20 minutes
* 5.Other reagents are added perfusion for regulation of donor renal function
Recipient:
* 1.Involved in other study.
* 2.Double organ or multi-organ transplant
* 3.A,B,O blood type-incompatible
18 Years
65 Years
ALL
No
Sponsors
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First Affiliated Hospital Xi'an Jiaotong University
OTHER
Responsible Party
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Ding Xiaoming
Director of renal transplant department
Principal Investigators
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xiaoming D Ding, PhD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital Xi'an Jiaotong University
Locations
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First Affiliated Hospital Xi'an Jiaotong University
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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References
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Allen AM, Kim WR, Xiong H, Liu J, Stock PG, Lake JR, Chinnakotla S, Snyder JJ, Israni AK, Kasiske BL. Survival of recipients of livers from donation after circulatory death who are relisted and undergo retransplant for graft failure. Am J Transplant. 2014 May;14(5):1120-8. doi: 10.1111/ajt.12700. Epub 2014 Apr 14.
Huang J, Millis JM, Mao Y, Millis MA, Sang X, Zhong S. A pilot programme of organ donation after cardiac death in China. Lancet. 2012 Mar 3;379(9818):862-5. doi: 10.1016/S0140-6736(11)61086-6. Epub 2011 Nov 10.
Huang J, Wang H, Fan ST, Zhao B, Zhang Z, Hao L, Huo F, Liu Y. The national program for deceased organ donation in China. Transplantation. 2013 Jul 15;96(1):5-9. doi: 10.1097/TP.0b013e3182985491.
World Health Organization. WHO guiding principles on human cell, tissue and organ transplantation. Transplantation. 2010 Aug 15;90(3):229-33. doi: 10.1097/TP.0b013e3181ec29f0. No abstract available.
Moers C, Leuvenink HG, Ploeg RJ. Non-heart beating organ donation: overview and future perspectives. Transpl Int. 2007 Jul;20(7):567-75. doi: 10.1111/j.1432-2277.2007.00455.x. Epub 2007 Jan 30.
Kokkinos C, Antcliffe D, Nanidis T, Darzi AW, Tekkis P, Papalois V. Outcome of kidney transplantation from nonheart-beating versus heart-beating cadaveric donors. Transplantation. 2007 May 15;83(9):1193-9. doi: 10.1097/01.tp.0000261710.53848.51.
Jochmans I, Darius T, Kuypers D, Monbaliu D, Goffin E, Mourad M, Ledinh H, Weekers L, Peeters P, Randon C, Bosmans JL, Roeyen G, Abramowicz D, Hoang AD, De Pauw L, Rahmel A, Squifflet JP, Pirenne J. Kidney donation after circulatory death in a country with a high number of brain dead donors: 10-year experience in Belgium. Transpl Int. 2012 Aug;25(8):857-66. doi: 10.1111/j.1432-2277.2012.01510.x. Epub 2012 Jun 13.
Chamorro C, Falcon JA, Michelena JC. Controversial points in organ donor management. Transplant Proc. 2009 Oct;41(8):3473-5. doi: 10.1016/j.transproceed.2009.09.004.
Gelb AW, Robertson KM. Anaesthetic management of the brain dead for organ donation. Can J Anaesth. 1990 Oct;37(7):806-12. doi: 10.1007/BF03006543.
Xue W, Tian P, Ding X, Pan X, Yan H, Hou J, Feng X, Xiang H, Tian X, Ren L, Zheng J, Li S. Clinical research and social status investigation for donor and recipient of living-related kidney transplant. Int Urol Nephrol. 2013 Feb;45(1):239-49. doi: 10.1007/s11255-012-0259-0. Epub 2012 Aug 15.
Wadei HM, Heckman MG, Rawal B, Taner CB, Farahat W, Nur L, Mai ML, Prendergast M, Gonwa TA. Comparison of kidney function between donation after cardiac death and donation after brain death kidney transplantation. Transplantation. 2013 Aug 15;96(3):274-81. doi: 10.1097/TP.0b013e31829807d1.
Singh RP, Farney AC, Rogers J, Zuckerman J, Reeves-Daniel A, Hartmann E, Iskandar S, Adams P, Stratta RJ. Kidney transplantation from donation after cardiac death donors: lack of impact of delayed graft function on post-transplant outcomes. Clin Transplant. 2011 Mar-Apr;25(2):255-64. doi: 10.1111/j.1399-0012.2010.01241.x.
Mallon DH, Summers DM, Bradley JA, Pettigrew GJ. Defining delayed graft function after renal transplantation: simplest is best. Transplantation. 2013 Nov 27;96(10):885-9. doi: 10.1097/TP.0b013e3182a19348.
Nagaraja P, Roberts GW, Stephens M, Horvath S, Fialova J, Chavez R, Asderakis A, Kaposztas Z. Influence of delayed graft function and acute rejection on outcomes after kidney transplantation from donors after cardiac death. Transplantation. 2012 Dec 27;94(12):1218-23. doi: 10.1097/TP.0b013e3182708e30.
Lodhi SA, Lamb KE, Uddin I, Meier-Kriesche HU. Pulsatile pump decreases risk of delayed graft function in kidneys donated after cardiac death. Am J Transplant. 2012 Oct;12(10):2774-80. doi: 10.1111/j.1600-6143.2012.04179.x. Epub 2012 Jul 23.
Other Identifiers
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XAC-01
Identifier Type: -
Identifier Source: org_study_id
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