Medication Use Evaluation for Enoxaparin in Hospitalized COVID-19 Patients

Venous Thromboembolism Clinical Trial

Official title:

Medication Use Evaluation for Enoxaparin in Hospitalized COVID-19 Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05226793
• Other study ID #: 054.PHA.2021.R
• Status: Recruiting
• Start date: November 17, 2021
• Est. completion date: November 17, 2024

Study information

• Verified date: March 2024
• Source: Methodist Health System
• Contact: Crystee Cooper, DHEd
• Phone: 214-947-1280
• Email: clinicalresearch[@]mhd.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: November 17, 2024
• Est. primary completion date: November 17, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
United States	Methodist Richardson Medical Center	Richardson	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enoxaparin dose (appropriate for kidney function)	Enoxaparin dose	2021-2022
Primary	Charlson comorbidity index (CCI) score	(CCI) score	2021-2022
Primary	Padua prediction score for risk of VTE	Padua prediction score	2021-2022
Primary	IMPROVE [International Medical Prevention Registry on VTE] bleeding risk assessment score	IMPROVE [International Medical Prevention Registry on VTE] bleeding risk assessment score	2021-2022
Primary	ICU status	ICU status	2021-2022
Primary	Number of thromboembolic events	Number of thromboembolic events	2021-2022
Primary	Length of stay	Days	2021-2022
Primary	Readmissions for DVT and/or PE	Readmissions for DVT and/or PE	2021-2022
Primary	In-hospital mortality with associated DVT or PE	In-hospital mortality with associated DVT or PE	2021-2022
Secondary	Bleeding events	Bleeding events	2021-2022
Secondary	Type of bleeding event	Type of bleeding event	2021-2022