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临床试验/NCT02493504
NCT02493504已完成4 期

Effects of Heparin on Early Patency of Arteriovenous Fistula in Angioaccess Surgery of Patients With End-Stage Renal Disease

Fatemeh Hoseinzadegan0 个研究点目标入组 150 人开始时间: 2011年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
150
主要终点
The number of patients with a bruit auscultated over AVF

研究概览

简要总结

Arteriovenous fistula (AVF) is now the optimal method of obtaining vascular access for dialysis. Measures such as systemic anticoagulation have been proposed as means of increasing patency rates but enough evidence does not exist to support their use. The investigators aimed to evaluate the efficacy of preoperative heparin injection on patency of AVF during the first 24 hours after surgery and to determine whether such measure can be used to prevent early thrombosis of the vascular access.

详细描述

The study was carried out on patients admitted to Shohada-e-Tajrish hospital for permanent vascular access placement since April 2011 through September 2012. The exclusion criteria consisted of having a contraindication of administration of anticuagulant agent. 150 patients were enrolled in the study.

All patients were operated on by a single surgeon (Dr Mozafar. The non dominant upper extremity (mostly the left arm) was generally used unless unfavorable vasculature or previous fistula placement changed the preference. The anastomosis technique was either end-to-side or side-to-side using a number 6.0 prolene suture. 75 patients were randomly assigned to receive 100units/kg of heparin after dissection prior to anastomosis while the other 75 received no intraoperative heparin injection. Auscultation of bruit and palpation of thrill was used to assess arteriovenous fistula patency in the first 24 hours after AVF placement.

Data analysis was performed using SPSS v.20. A p-value of less than 0.05 was considered as statistically significant. Bivariate analysis in the form of Chi-square tests, T-test and Fischer's exact test were calculated.

Patient enrollment was voluntary and no costs were imposed on the patients. The study protocol was in accordance with 1975 Declaration of Helsinki.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Chronic Kidney Disease, In need of AVF placement

排除标准

  • Contraindications for anticoagulant therapy

研究组 & 干预措施

Heparin

Experimental

75 patients were randomly assigned to receive 100units/kg of heparin after dissection prior to anastomosis.

干预措施: Heparin (Drug)

结局指标

主要结局

The number of patients with a bruit auscultated over AVF

时间窗: The first 24 hours after anostomosis

Hearing a bruit through auscultation over the AVF is regarded as a positive measure or in other words a patent AVF. The frequency of positive measures are compared between the two groups.

次要结局

未报告次要终点

研究者

发起方
Fatemeh Hoseinzadegan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Fatemeh Hoseinzadegan

Dr.

Shahid Beheshti University of Medical Sciences

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