Evaluation of Enoxaparin Dosing in Hospitalized Morbidly Obese Patients at an Academic Medical Center
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Proportion of Patients With an Initial Therapeutic Anti-Xa Level at Steady State in Each Group
研究概览
简要总结
The purpose of this study is to determine an effective enoxaparin dosing strategy in medically ill, morbidly obese patients. This study will include adult patients greater than 18 yrs of age being admitted to Grady Hospital in Atlanta, GA. Potentially vulnerable patients such as prisoners, children, and pregnant women will not be enrolled in the study. Study participants will be contacted in person by the study personnel once inclusion criteria are met. Written informed consent will be obtained in person while hospitalized. Once the patient is consented they will be given enoxaparin and blood samples will be drawn. The data collected will be from the electronic medical record which is accessed only with a username and password so it is not publicly available. The data will be identifiable upon collection and will be kept on a password protected file on a computer in a locked office. The data will be de-identified after data analysis and only the study personnel will have access to the code that links identifiers to subjects. A HIPAA waiver will be requested to access existing data in order to identify patients for enrollment. All data will be collected in an office in the hospital. The study participants' burden will be minimal and dependent only on time of consent process since morbidly obese patients would be receiving this blood sample collection regardless of their participation in the study.
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
- •Planned treating with twice daily enoxaparin
- •BMI >= 40 kg/m2
排除标准
- •< 18 years of age
- •CrCl < 30 ml/min
- •Pregnancy
- •Active bleeding
- •Already received 3 consecutive doses of enoxaparin
- •Use of therapeutic enoxaparin for more than 5 consecutive days within the last 3 months
研究组 & 干预措施
Reduced Dose (0.8 mg/kg)
Enoxaparin 0.8 mg/kg (using total body weight) twice daily
干预措施: Enoxaparin (Drug)
Standard Dose (1 mg/kg)
Enoxaparin 1 mg/kg (using total body weight) twice daily
干预措施: Enoxaparin (Drug)
结局指标
主要结局
Proportion of Patients With an Initial Therapeutic Anti-Xa Level at Steady State in Each Group
时间窗: 3-5 hours after at least 3rd dose
次要结局
- Time to Therapeutic Anti-Xa Level for Both Groups(Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days)
研究者
Christine Kempton, MD, MSc
Associate Professor, Department of Pediatrics and Department of Hematology and Medical Oncology
Emory University
