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临床试验/ACTRN12619000416190
ACTRN12619000416190招募中未知

Hemodialysis without Systemic Anticoagulation: A Prospective Randomized Trial to Evaluate Five Strategies in Patients at High Risk of Bleeding

Pedro Henrique Franca Gois0 个研究点目标入组 200 人开始时间: 2019年3月13日最近更新:
适应症

试验速览

阶段
未知
状态
招募中
发起方
入组人数
200

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Prevention
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • Individuals with end stage renal failure on maintenance HD or HDF for more than 3 months;
  • In-centre dialysis; high risk of bleeding (at the discretion of the assisting renal physician);
  • Native or graft arteriovenous fistula with blood flow at least 250 ml/min;
  • Patients with a tunnelled catheter locked by heparin can be included in the study after removal of heparin and rinsing the catheter prior to starting the treatment;
  • Minimum age of 18 years with no gender restriction.

排除标准

  • Dialysis in the intensive care unit;
  • Patients with acute kidney injury;
  • Patients treated in single needle mode;
  • Known heparin contraindication (e.g. heparin-induced thrombocytopenia type II);
  • Patients requiring blood products;
  • Patients receiving oral anticoagulants (including anti-vitamin K) (> 3 days since treatment stopped and/or normalized international normalized ratio will be allowed);
  • Patients receiving a combination of anti-platelet agents (> 5 days since treatment stopping will be allowed);
  • Patients currently on unfractioned (UFH) or low molecular weight heparin (LMWH) for treatment of deep vein thrombosis;
  • Patients treated with UFH or LMWH to prevent deep vein thrombosis (24 hours since last dose of LMWH or 12 hours since last dose of UFH was allowed).
  • Patients with laboratory markers of liver dysfunction (ALT and AST more than double of upper borderline lab value);
  • Patients with known coagulopathy or haemostasis disorder (pathological value of prothrombin time and aPTT, and platelets less than 50,000/ul);
  • Patients with the diagnosis of malignancy.

研究者

发起方
Pedro Henrique Franca Gois

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