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
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