NCT02876692

Prediction and Management of Delayed Graft Function Based on Donor Criteria and LifePort Platform

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective cohort study: 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

Detailed description

Subjects are enrolled to collect the data of donors and recipients. Investigators also collect the data of recipients or donated organs as following: physiological and biochemical indexes, machine perfusion parameters, and the other factors effected on renal transplant outcomes. A Cox proportional hazards model and multiple linear regression analysis will be applied to examine the correlation among the univariate and multivariate. Based on the above analysis to improve the new scoring system, Lifeport work platform evaluation system and donor kidney quality evaluation system. Then, a multi-center clinical trial will be started to improve and verify the new scoring system. Finally, a donor kidney evaluation APP will be developed based on the scoring system and the database of clinical trials. An applicaiotion (APP) will be popularized the national transplant surgeons.

Conditions

• Delayed Graft Function

Interventions

Type	Name	Description
DEVICE	Machine perfusion	Deceased donor kidneys were preserved by hypothermic machine perfusion

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-12-01
• Completion: 2019-12-01
• First posted: 2016-08-24
• Last updated: 2016-09-01

Locations

1 site across 1 country: China