Medication Use Evaluation for Enoxaparin in Hospitalized COVID-19 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Enoxaparin dose (appropriate for kidney function)
研究概览
简要总结
Retrospective chart review to be conducted at Methodist Richardson Medical Center (MRMC) in Richardson, TX. All adult patients hospitalized with COVID-19 on enoxaparin for DVT prophylaxis will be included. Collected data will be analyzed to determine the safety and effectiveness of the varying enoxaparin doses, and results will be presented at the American Society of Health-System Pharmacists Midyear conference in December 2022.
详细描述
Retrospective chart review to be conducted at Methodist Richardson Medical Center (MRMC) in Richardson, TX. All adult patients hospitalized with COVID-19 on enoxaparin for DVT prophylaxis will be included. Collected data will be analyzed to determine the safety and effectiveness of the varying enoxaparin doses, and results will be presented at the American Society of Health-System Pharmacists Midyear conference in December 2022.
EPIC will be queried for data for this medication use evaluation, including the patient's age, sex, weight/BMI, ICU status, maximum D-dimer level, enoxaparin dose received, development of DVT or PE, incidence and type of bleeding events, readmission status, and mortality. Other patient specific factors such as the CCI score, Padua score, and IMPROVE score will be calculated using online risk assessment tools.
To calculate the CCI score, a search function will be used to analyze the patient's health information in order to determine their age, history of myocardial infarction, congestive heart failure, peripheral vascular disease, stroke or transient ischemic attack, dementia, chronic obstructive pulmonary disease, connective tissue disease, peptic ulcer disease, liver disease, diabetes mellitus, kidney function, cancer status, blood dyscrasias, and HIV status to estimate their 10-year probability of survival.
To calculate the Padua score, each patient must be evaluated for cancer status, history of VTE, mobility status, history of thrombophilic conditions, recent trauma or surgery, age, heart and/or respiratory failure, acute myocardial infarction and/or respiratory failure status, acute infection and/or rheumatologic disorder, obesity, and ongoing hormonal treatment. If a patient scores a 4 or more, then pharmacologic prophylaxis would be indicated.
Lastly, to calculate each patient's bleeding risk, the IMPROVE bleeding risk assessment will be used. For this tool, the patient's age, gender, renal function, liver function, platelet count, ICU status, the presence of a central venous catheter, active gastrointestinal ulcer, history of bleeding in the previous three months, presence of rheumatic disease, and active malignancy are needed to calculate the risk. If the patient scores a 7 or higher on the assessment, they are at an increased risk for bleeding.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Effectiveness of intermediate-intensity vs standard prophylactic enoxaparin regimens on preventing DVT and/or PE in patients with COVID-19, measured using the following variables:
- •Enoxaparin dose (appropriate for kidney function)
- •Charlson comorbidity index (CCI) score
- •Padua prediction score for risk of VTE
- •IMPROVE [International Medical Prevention Registry on VTE] bleeding risk assessment score
- •ICU status
- •Number of thromboembolic events
- •Length of stay
- •Readmissions for DVT and/or PE
- •In-hospital mortality with associated DVT or PE
排除标准
- •Safety of intermediate-intensity vs standard prophylactic enoxaparin regimens in patients with COVID-19, measured using the following variables:
- •Bleeding events
- •Type of bleeding event
结局指标
主要结局
Enoxaparin dose (appropriate for kidney function)
时间窗: 2021-2022
Enoxaparin dose
Charlson comorbidity index (CCI) score
时间窗: 2021-2022
(CCI) score
ICU status
时间窗: 2021-2022
ICU status
Number of thromboembolic events
时间窗: 2021-2022
Number of thromboembolic events
Length of stay
时间窗: 2021-2022
Days
Padua prediction score for risk of VTE
时间窗: 2021-2022
Padua prediction score
Readmissions for DVT and/or PE
时间窗: 2021-2022
Readmissions for DVT and/or PE
IMPROVE [International Medical Prevention Registry on VTE] bleeding risk assessment score
时间窗: 2021-2022
IMPROVE \[International Medical Prevention Registry on VTE\] bleeding risk assessment score
In-hospital mortality with associated DVT or PE
时间窗: 2021-2022
In-hospital mortality with associated DVT or PE
次要结局
- Bleeding events(2021-2022)
- Type of bleeding event(2021-2022)
