Three Anticoagulation Strategies for Hemodialysis in Patients at Risk of Hemorrhage: a Multicenter Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- therapy interruption event
研究概览
简要总结
The aim of our study is to assess three anticoagulation strategies for intermittent hemodialysis(IHD) in patients at risk of hemorrhage. A registry of consecutive hemodialysis patients with high risk of hemorrhage was conducted at the Guangdong General Hospital, the First Affiliated Hospital of Guangzhou University of Chinese Medicine, the Second Affiliated Hospital of Guangzhou Medicine University or Guangzhou Hospital of Chinese Medicine, between Sep 10, 2017 and June 30th,2018. In this multi-center prospective and randomized study, participants were randomly divided into three groups during IHD according to different anticoagulation, including with regular saline flushes, one stage regional citrate anticoagulation (RCA) and two-stage RCA.
详细描述
Briefly, there are two parts in this study. The first part of the study is to compare two-stage RCA with one stage RCA during IHD, and the second part is to compare two-stage RCA with regular saline flushes, with estimated total procedures, 78 and 48, respectively. The primary outcome was measured as therapy interruption based on visible serious circuit clotting or persistent alarms such as venous pressure (> 200 mmHg) or TMP(transmembrane pressures) (> 300 mmHg). The secondary outcomes included circuit survival time, the total clotting score of ECC(extracorporeal circuit ) and urea clearance (Kt/V and URR). The total clotting score was the sum of the clotting scores for the venous expansion chamber, arterial expansion chamber, and dialyzer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •age>=18 years
- •intermittent hemodialysis patients that carry on a 4 hours hemodialysis procedure, 2-3 times one week.
- •the therapy mode is hemodialysis，with a dialysis fluid more than 500ml/min and blood flow volume more than 3.5-4ml/min.kg；
- •at risk of hemorrhage,including active hemorrhage(within 3 days),post-operation(within 3 days) and pre-invasive operation(within 7 days).
排除标准
- •at high risk of citrate accumulation( total bilirubin >60umol/L; lactic acid>3mmol/L,）；
- •use the drugs that impact the coagulation function within 7 days;
- •serious hypocalcemia (serum calcium<1.9mmol/L).
研究组 & 干预措施
saline flushes
saline flushes with 250 mL were carried out every 30 min.
干预措施: two stage regional citrate (Drug)
one stage regional citrate
one stage regional citrate:4% trisodium citrate was infused at the arterial bubble trap at a rate according to the blood flow( 1.2 x blood flow)ml/h.
干预措施: one stage regional citrate (Drug)
two stage regional citrate
two stage regional citrate:4% trisodium citrate was infused at the arterial bubble trap at a rate according to the blood flow(3/4 x 1.2 x blood flow)ml/h,and at the venous bubble trap at a rate according to the blood flow(1/4 x 1.2 x blood flow)ml/h.
干预措施: two stage regional citrate (Drug)
two stage regional citrate
two stage regional citrate:4% trisodium citrate was infused at the arterial bubble trap at a rate according to the blood flow(3/4 x 1.2 x blood flow)ml/h,and at the venous bubble trap at a rate according to the blood flow(1/4 x 1.2 x blood flow)ml/h.
干预措施: one stage regional citrate (Drug)
结局指标
主要结局
therapy interruption event
时间窗: through study completion, from start to four hours
visible serious circuit clotting or persistent alarms such as venous pressure (\> 200 mmHg) or TMP (\> 300 mmHg)dialyzer
次要结局
- the clotting scores(through study procedure,an average of four hours)
- urea clearance(through study procedure,an average of four hours)