ACTRN12613001376730尚未招募3 期
A prospective, randomised comparison in hospitalised patients re-commenced on warfarin post-operatively at the usual maintenance dose versus a loading dose strategy to assess time to a stable therapeutic INR.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 186
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 100 Years（—）
- 性别
- All
入选标准
- •> 18 years old, receiving ongoing warfarin therapy, undergoing elective surgery, able to provide written, informed consent, and followed-up by Hospital-at-Home services for INR monitoring
排除标准
- •Unable to provide written, informed consent
- •Not followed-up by Hospital-at-Home until a stable therapeutic INR is achieved
- •Undergoing cardiac surgery (note – patients with pre-existing artificial mitral or aortic valves are eligible as long as the surgery is not cardiac)
- •Surgery expected to grossly prevent normal oral intake in the week post-operatively eg colon resection
- •Use of more than 2 mg of vitamin K, fresh frozen plasma, or Prothrombinex-VT for INR reversal immediately pre-operatively
- •Use of any vitamin K, fresh frozen plasma, or Prothrombinex for INR reversal in the week after surgery, prior to a stable therapeutic INR being achieved. Normal blood transfusions are permissible and will be considered as a sub-group.
- •Commencement of regular therapy with drugs known to interact with warfarin in the period between the most recently measured maintenance INR and the commencement of surgery, excluding routine drugs administered immediately prior to surgery, such as antibiotic prophylaxis. This includes, imidazole antifungals, macrolide antibiotics, fluoroquinolones, amiodarone, omeprazole, metronidazole, cholestyramine, carbamazepine, phenytoin, barbiturates, rifampicin, sulfamethoxizole/trimpethoprim, SSRI’s, thyroxine, NSAIDs.
- •Lack of reliable INR results with corresponding maintenance dose
- •Most recent routine maintenance dose INR below 1.5 or above 3.5 for patients with a therapeutic range of 2-3, or above 4.0 for patients with a therapeutic range of 2.5-3.5
- •Warfarin reversed during warfarin re-commencement period due to unexpected return to theatre
研究者
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