NCT01930396已完成4 期
Intermittent HEMOdialysis Anticoagulation With TINzaparin Versus Unfractionated Heparin: A Pilot Multicentre Randomized Controlled Trial (HEMO-TIN Trial)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 191
- 试验地点
- 1
- 主要终点
- Rate of major, clinically important non-major or minor bleeding
研究概览
简要总结
The HEMO-TIN trial is designed to look at both the safety (bleeding risk) and effectiveness (clotting risk) of tinzaparin compared with unfractionated heparin for anticoagulation in hemodialysis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •End stage renal disease maintained on outpatient hemodialysis for >= 3 months
- •Frequency of hemodialysis: 3 times per week
- •Anticoagulation with an unfractionated heparin protocol for at least 4 weeks
- •Patient or legal guardian able to provide written consent
- •Baseline INR <= 1.3
- •Baseline platelet count >= 80,000 x 10^9/L
排除标准
- •Therapeutic systemic anticoagulation
- •Clinically apparent bleeding in the last 2 months
- •High risk of bleeding
- •Planned major surgery in the next 4 months
- •Major surgery in the past 48 hours
- •Pregnant or lactating
- •Child bearing potential
- •Allergy/intolerance to heparin or history of heparin induced thrombocytopenia
- •Current participation in a related randomized drug trial
研究组 & 干预措施
Unfractionated Heparin
Active Comparator
干预措施: Placebo (for Tinzaparin) (Drug)
Tinzaparin
Experimental
干预措施: Tinzaparin (Drug)
Tinzaparin
Experimental
干预措施: Placebo (for Unfractionated Heparin) (Drug)
Unfractionated Heparin
Active Comparator
干预措施: Unfractionated Heparin (Drug)
结局指标
主要结局
Rate of major, clinically important non-major or minor bleeding
时间窗: 26 weeks
次要结局
- Clotting in extracorporeal dialysis circuit(During Hemodialysis (weekly for 26 weeks))
研究者
Christine Ribic
Nephrologist
St. Joseph's Healthcare Hamilton
研究点 (1)
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