Effects of Different Concentrations of Pressurized-heparin Flushing Fluid on Coagulation and Platelet Function Monitored by the Sonoclot Analyzer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The level of glass bead Activated Clotting Time
研究概览
简要总结
Heparin diluent or normal saline is generally used as the arterial tube flushing in clinical practice, but there is no consensus on the choice of flushing fluid. Heparin can affect the blood coagulation function, and even lead to heparin-related thrombocytopenia, increasing the risk of perioperative embolism. Sonoclot is a blood viscoelasticity test, which can provide comprehensive information on the coagulation's cascade and the entire process and be quicker and more effective than routine laboratory coagulation tests. In this research, the coagulation and platelet function analyzer called Sonoclot is used to evaluate the effect of different concentrations of pressurized heparin on the coagulation and platelet function of perioperative patients, which can provide a reference for the clinical choice of appropriate arterial flushing.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of gastrointestinal cancer
- •Ages ranged from 18 to 75
- •ASA I~III
排除标准
- •Pregnancy
- •modified Allen Test negative
- •history of taking anti-platelet drugs such as aspirin one week before surgery, heparin allergy and thrombotherapy
- •two failed catheterizations of the same artery
- •significant diseases in liver and kidney function
- •refusal of patients
研究组 & 干预措施
Heparin with a concentration of 2 U/ml
heparin dilution is placed in a pressure bag with a pressure of 300 mmHg
干预措施: Heparin (Drug)
Heparin with a concentration of 4 U/ml
heparin dilution is placed in a pressure bag with a pressure of 300 mmHg
干预措施: Heparin (Drug)
normal saline
normal saline is placed in a pressure bag with a pressure of 300 mmHg
干预措施: normal saline (Drug)
结局指标
主要结局
The level of glass bead Activated Clotting Time
时间窗: through study completion, an average of 3 minute
10 min after the vein puncture, 2 h after skin incision and at the end of surgery
次要结局
- The amount of infusion volume, blood loss, urine volume(intraoperative)
- The level of glass bead Clot Rate(through study completion, an average of 3 minute)
- The level of glass bead Platelet Function(through study completion, an average of 3 minute)
- The level of platelet count(through study completion, an average of 2 minute)
- The frequencies of hand positional changes and manual artery flushing(intraoperative)
- The appearance of local complications of arterial puncture(within 24 h after surgery)
研究者
Zhuan Zhang
Director
Yangzhou University