Effect of Vitamin K in Critically Ill Patients With Spontaneously Increased Pro-thrombin Time Measured With Routine Coagulation Tests and Advanced Coagulation- and Vitamin K-assays
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change in prothrombin complex (PK-INR)
研究概览
简要总结
Critically ill patients with spontaneously prolonged pro-thrombin time, where administration of intravenous administration of phytomenadione (vitamin K) has been ordered by the treating physician will be identified. After signed informed consent baseline samples will be collected. Phytomenadione will be given and 24 hours after administration new blood samples will be collected. Several different advanced coagulation and vitamin K-assays will be performed before and 24 hours after vitamin K administration.
详细描述
Vitamin K-deficiency is common in the peri-operative and intensive care setting. It is often seen in patients with prolonged prothrombin complex (PK-INR). A prolonged (PK-INR) is sometimes treated with intravenous vitamin K, even in non-warfarin treated or non-liver failure patients. Despite the development of this practice the knowledge about how intravenously given vitamin K affects routine coagulation status and other advanced laboratory coagulations assays is rare.
The aim of this study is to investigate the effects of intravenously administered vitamin K on routine coagulation status and on advanced coagulation and vitamin K-assays in post-operative- and critically ill patients with prolonged PK-INR.
Patients with spontaneously prolonged PK-INR are routinely given intravenous vitamin K but it is largely unknown how this procedure affects the included coagulation assays. This research project may contribute to increased knowledge concerning effects of intravenously given vitamin K in critical ill patients with spontaneous coagulopathies. Since spontaneous coagulopathy is frequently occurring in critically ill and postoperative patients due to various underlying conditions and current evidence for vitamin K administration is based on scarce evidence more research in this area is motivated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Critically ill patients at the postoperative care unit or at the intensive care unit with a prothrombin complex (PK-INR) > 1.2 during office hours who are ordered parenteral phytomenadione 10 mg will be eligible for inclusion
排除标准
- •Warfarin treatment
- •Treatment with novel oral anticoagulants
- •Hepatocellular carcinoma
- •Liver resection within 6 months
- •Known pre-existing coagulopathy
研究组 & 干预措施
Patients with increased PK-INR
Critically ill patients with spontaneously increased prothrombin complex (PK-INR) who are given phytomenadione intravenously at the discretion of the treating physician
干预措施: Phytomenadione (Drug)
结局指标
主要结局
Change in prothrombin complex (PK-INR)
时间窗: Before and 24 hours after given phytomenadione
Prothrombin complex (PK-INR) with Owren and Quick reagents
次要结局
- Change in concentration of PIVKA-II in plasma(Before and 24 hours after given phytomenadione)
- Change in concentration of protein C and S in plasma(Before and 24 hours after given phytomenadione)
- Change in thromboelastometry assay in whole blood(Before and 24 hours after given phytomenadione)
- Change in concentration of coagulation factors II, VII, IX and X in plasma(Before and 24 hours after given phytomenadione)
- Change in concentration of dp-ucMGP in plasma(Before and 24 hours after given phytomenadione)
- Change in thrombin generation assay in plasma(Before and 24 hours after given phytomenadione)