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临床试验/CTRI/2024/12/078593
CTRI/2024/12/078593尚未招募2/3 期

Evaluation of the role of Platelet rich plasma in overall success rates of AV fistula in patients with End stage renal disease A randomized study

AIIMS Bhubaneswar1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2025年1月11日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
78
试验地点
1
主要终点
Two co-primary end points

研究概览

简要总结

The hall mark of End-stage renal disease (ESRD) is  a progressive decline of kidney function.

 Despite the advancements in hemodialysis techniques, the success rates of AVFs, a preferred method for Vascular access, remain suboptimal, with some studies reporting only 50 to 61 % success rates. In the quest for improving AVF outcomes, one promising direction in tissue healing is the application of platelet-rich plasma (PRP). It stimulates cellular pathways necessary for tissue regeneration, making it an attractive option for enhancing the success of AVF creation. This study aims to explore the impact of PRP on improving primary patency rates in patients undergoing AVF creation for ESRD. By leveraging the regenerative properties of PRP, this research seeks to provide a viable solution to enhance the success rates of AVFs, thereby improving the overall management and quality of life for ESRD patients.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • include age over 18 years with ESRD requiring hemodialysis.

排除标准

  • Critical thrombocytopenia (low platelet count) Hypofibrinogenaemia Haemodynamic instability (collapse) Acute and chronic infections Chronic liver disease Anti-coagulation therapy (warfarin, dabigatran, heparin) Platelet dysfunction syndrome Local infection at the site of the procedure Hemodialysis port on the Same side.

结局指标

主要结局

Two co-primary end points

时间窗: Measured at 4th , 6th and 12 th week after AVF creation

1. AVF diameter

时间窗: Measured at 4th , 6th and 12 th week after AVF creation

2. AVF blood flow

时间窗: Measured at 4th , 6th and 12 th week after AVF creation

次要结局

  • Time to successful cannulation(Time to initiation of Hemodialysis.)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Pranjal Chowdhury

AIIMS Bhubaneswar

研究点 (1)

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