Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients: An Investigator Initiated Protocol
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 27
- 主要终点
- Bleeding events
研究概览
简要总结
This is a pilot study to evaluate safety of fondaparinux and enoxaparin in terms of bleeding and development of thrombocytopenia in the medical ICU population.
详细描述
This is a pilot study to evaluate safety of fondaparinux and enoxaparin in terms of bleeding and development of thrombocytopenia in the medical ICU population. We expect the null hypothesis to be proven true. One hundred subjects will be enrolled in this prospective, randomized, double-blind (concealed allocation) pilot study of consecutive medical ICU patients to one of two pharmacologic VTE prophylaxix treatment arms. (1) Primary endpoints include hemoglobin, hematocrit, & platelet counts. blood product utilization, bleeding complications (any), Steady State Functional Factor Xa activity (for post hoc analysis), non-study pharmacologic VTE prophylaxis (when estimated CLcr < 30ml/min), and days not treated with study drug or treated with alternative agent Secondary/ Additional Data to be collected include patient demographics, primary & secondary diagnoses, central venous access, and sequential compression device utilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability or legally authorized representative (LAR) to provide informed consent
- •Adult who has not had surgery within 10 days, admitted to the Sentara Norfolk General Hospital ICU Medical Teaching Services for any reason.
排除标准
- •Active or suspected bleeding
- •Platelet count less than 100,000 per microliter (mm3) of blood
- •Thrombolytic or anticoagulant treatment (including any doses of prophylactic UFH, LMWH or fondaparinux) during the current hospitalization
- •Initial estimated CLcr < 30 ml/min as determined by the Cockcroft-Gault equation
- •Initial labs indicative or suggestive of rapidly rising serum Creatinine (>1 mg/dL/day)
- •Pregnancy (for medicolegal considerations)
- •Patients with or expecting to require an epidural catheter
- •Patients who are expected to have an immediate (within 24h) need for surgery
研究组 & 干预措施
Fondaparinux
Fondaparinux treatment - one standard of care option
干预措施: Fondaparinux (Drug)
2
Enoxaparin
干预措施: Enoxaparin (Drug)
结局指标
主要结局
Bleeding events
时间窗: inpatient hospitalization
次要结局
- Development of thrombocytopenia(inpatient hospitalization)