Prospective CYP2C9 And VKORC1 Genotyping For Total Hip or Knee Replacement Patients Receiving Warfarin (Coumadin)For Anticoagulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 263
- 试验地点
- 2
- 主要终点
- The Number of Participants With Adverse Events Associated With Warfarin Anticoagulation Following Total Hip and Total Knee Replacement
研究概览
简要总结
Several human genes affect how medications are metabolized by the body. It is believed that knowledge of variations of these genes can help health care providers better manage an anticoagulation medicine called warfarin (Coumadin®)and as a result decrease patient problems with bleeding or the development of blood clots. This study was designed to evaluate if genetic testing can improve warfarin initiation better than usual care.
详细描述
This study was completed in 2008 and was published. Consult the citation link for more details.
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
- 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
- •Participants were otherwise healthy adults (≥ 18 years of age) who were planning total hip or knee replacement or revision surgery at the University of Utah Hospital, and scheduled a pre-operative office visit at the University of Utah Orthopaedic Center.
排除标准
- •Blood transfusion in previous two weeks
- •Participant is already taking warfarin
- •Pre-operative INR > 4.0
- •Pre-operative bilirubin > 2.4 mg/dL
- •Current active cancer diagnosis with ongoing treatment
- •Concomitant medications known to exert a major interaction with warfarin such as septra, metronidazole, tramadol, amiodarone, ciprofloxacin, or cimetidine.
结局指标
主要结局
The Number of Participants With Adverse Events Associated With Warfarin Anticoagulation Following Total Hip and Total Knee Replacement
时间窗: 90 days post surgery
Adverse events were defined as 1. Major bleeding: fatal bleeding, bleeding into a critical organ, bleeding that requires hospital admission 2. Minor bleeding: clinically overt bleeding not meeting criteria for major bleeding 3. Symptomatic deep vein thrombosis (DVT) 4. Pulmonary embolism (PE)
次要结局
- Percentage of Determinations in Therapuetic Range (INR 1.8-2.9)(2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty))
- Percentage of Determinations Subtherapeutic (INR<1.8)(2 weeks (knee arthroplasty) or 4 weeks (hop arthroplasty))
- Percentage of Determinations Supratherapeutic (INR>2.9)(2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty))
研究者
Gwen McMillin
Medical Director Toxicology and Trace Minterals, Department of Pathology, ARUP Laboratories
University of Utah