跳至主要内容
临床试验/NCT05600634
NCT05600634招募中不适用

Multi Center Clinical Observation of Sentinel Skin Graft From the Same Donor Source for Detecting Acute Rejection After Renal Transplantation

Second Affiliated Hospital, School of Medicine, Zhejiang University3 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
24
试验地点
3
主要终点
2017 Banff Kidney Transplantation Rejection Rating

研究概览

简要总结

The purpose of this study was to explore the accuracy of sentinel skin grafts from the same donor source in diagnosing renal allograft rejection, and to provide new ideas and options for the later clinical diagnosis of renal allograft rejection. Further, try to provide timing guidance for early immunization intervention.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with end-stage renal disease undergoing renal transplantation;
  • 18-60 years old;
  • Postoperative follow-up points are complete (visit the hospital every week in the first month after surgery, every two weeks in 2-3 months, every four to six months, and every three months in 7-12 months. Follow up at any time when skin rejection is observed. The follow-up time may be adjusted when the condition changes);
  • The participants had good compliance, volunteered to participate in the test and signed the informed consent form.

排除标准

  • Untreated or disseminated malignant tumor;
  • Active period of infectious diseases;
  • Serious cardiovascular disease occurred recently;
  • Combined with other important organ failure;
  • History of mental illness or cognitive impairment;

结局指标

主要结局

2017 Banff Kidney Transplantation Rejection Rating

时间窗: Through study completion, an average of 1 year

A rating evaluation on kidney rejection

2007-edition Banff skin containing allogeneic composite histopathological diagnosis grading

时间窗: Through study completion, an average of 1 year

Skin histopathological diagnosis

Renal function testing

时间窗: Through study completion, an average of 1 year

Blood Cr and Bun testing

次要结局

  • Renal ultrasound diagnosis(Through study completion, an average of 1 year)
  • Complications(Through study completion, an average of 1 year)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (3)

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