跳至主要内容
临床试验/NCT05226793
NCT05226793已完成不适用

Medication Use Evaluation for Enoxaparin in Hospitalized COVID-19 Patients

Methodist Health System1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2021年11月17日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验