Clinical trial NCT05226793: Medication Use Evaluation for Enoxaparin in Hospitalized COVID-19 Patients
Official title: Medication Use Evaluation for Enoxaparin in Hospitalized COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Venous Thromboembolism
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients age 18 years or older hospitalized with COVID-19 on prophylactic/non-therapeutic enoxaparin from January 1, 2021 to January 31, 2021

Patients that do not have any other indication for use of enoxaparin (i.e., active DVT/PE, atrial fibrillation, etc.)

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Enoxaparin dose (appropriate for kidney function)
timeFrame: 2021-2022
measure: Charlson comorbidity index (CCI) score
timeFrame: 2021-2022
measure: Padua prediction score for risk of VTE
timeFrame: 2021-2022
measure: IMPROVE [International Medical Prevention Registry on VTE] bleeding risk assessment score
timeFrame: 2021-2022
measure: ICU status
timeFrame: 2021-2022
measure: Number of thromboembolic events
timeFrame: 2021-2022
measure: Length of stay
timeFrame: 2021-2022
measure: Readmissions for DVT and/or PE
timeFrame: 2021-2022
measure: In-hospital mortality with associated DVT or PE
timeFrame: 2021-2022
Secondary outcomes:
measure: Bleeding events
timeFrame: 2021-2022
measure: Type of bleeding event
timeFrame: 2021-2022
Other outcomes:
Locations:
city: Richardson
country: United States
facility: Methodist Richardson Medical Center
state: Texas
Study officials:
affiliation: Methodist
name: Betina Daniel, PharmD
role: PRINCIPAL_INVESTIGATOR
References: