STUDIO CLINICO RANDOMIZZATO SULL'UTILIZZO DI EPARINA PER LA PROFILASSI DELLA TROMBOFLEBITE DA CATETERE VENOSO PERIFERICO
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 214
- 试验地点
- 2
- 主要终点
- Phlebitis or Occlusion
研究概览
简要总结
Flushes with saline solution are used for maintaining patency of peripheral intermittent intravenous catheters in many institution based on the results of previous studies showing that 10 U heparin/mL is not better than saline in this respect. The latest meta-analysis investigated also safety and efficacy of heparin concentrations of 100 U/ml used as an intermittent flush, but no firm conclusion was reached because of limitations of the few available studies.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •requiring i.v. therapy for an expected duration longer than five days
- •admitted to the 3rd medical ward of IRCCS Policlinico San Matteo
排除标准
- •bleeding tendency
- •platelet count less than 100 x 109/L
- •coagulation defects
- •previous adverse reaction to heparin
- •programmed cytotoxic therapy
- •inability to give an informed consent
结局指标
主要结局
Phlebitis or Occlusion
Phlebitis is defined as the presence of two or more symptoms/signs among pain, tenderness, warmth, erythema, swelling, or a palpable cord (score of ≥ 2 according to the Visual Infusion Phlebitis Score). Occlusion is defined as resistance to flushing as evidenced by the inability to administer 1 ml of flushing solution within 30 seconds.
次要结局
- Ecchymosis
- Heparin induced thrombocytopenia