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临床试验/CTRI/2026/01/100520
CTRI/2026/01/100520尚未招募不适用

Comparison of Efficacy of Arteriovenous Fistula (AVF) Creation in Chronic Renal Failure for Hemodialysis Access — Using vs Not Using Subcutaneous Low-Molecular-Weight Heparin (LMWH): A Randomized Controlled Trial

All India Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1

研究概览

简要总结

Arteriovenous fistula (AVF) creation is the preferred vascular access for hemodialysis, yet early failure rates remain high—often 20–50 percent—mainly due to early thrombosis and poor maturation. These complications delay effective dialysis, increase reliance on temporary catheters, and lead to higher morbidity and healthcare costs. Low-molecular-weight heparin (LMWH) may reduce perioperative thrombosis by improving vessel patency during the critical early postoperative period. However, existing evidence is limited, inconsistent, and lacks rigorous randomized trials, particularly regarding safety concerns such as bleeding or hematoma formation. A well-designed randomized controlled study is therefore necessary to determine whether perioperative LMWH can improve early AVF patency and maturation without increasing complications. This trial aims to generate reliable data to guide clinical practice and optimize outcomes for patients requiring hemodialysis access.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Adult patients aged 18 years to 75 yrs of age with stage 4 or 5 CKD.
  • Patients with systolic B.P. more than 100 mmHg Suitable vascular anatomy confirmed by doppler usg arterial and venous diameter more than 2 mm.
  • Stable cardiovascular status • No history of previous AV fistula creation in intended arm.

排除标准

  • Previous vascular surgery on target arm Inadequate arteries or veins for fistula creation (eg: severe stenosis, occlusion, calcification).
  • H/O injection or blood sampling or injection in the arm where av fistula is to be created Patients with connective tissue disorders , vasculitis.
  • • Severe uncontrolled comorbidities like: heart failure, coagulopathy, bleeding disorders, severe diabetes with advanced neuropathy or poor wound healing.

研究者

申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dharmendra Kumar Pipal

All India Institute of Medical Sciences, Gorakhpur

研究点 (1)

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