Evaluating Enoxaparin Use in Hospitalized COVID-19 Patients
Medication Use Evaluation for Enoxaparin in Hospitalized COVID-19 Patients
Methodist Health System · NCT05226793
This study looks at how safe and effective different doses of enoxaparin are for hospitalized COVID-19 patients to see if it helps prevent blood clots and bleeding.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Methodist Health System (other) |
| Locations | 1 site (Richardson, Texas) |
| Trial ID | NCT05226793 on ClinicalTrials.gov |
What this trial studies
This observational study involves a retrospective chart review of adult patients hospitalized with COVID-19 who received enoxaparin for DVT prophylaxis at Methodist Richardson Medical Center. The study aims to analyze the safety and effectiveness of different enoxaparin dosing regimens by examining various patient-specific factors and outcomes, including the incidence of DVT, PE, and bleeding events. Data will be collected from electronic health records and assessed for its impact on patient outcomes, with findings to be presented at a professional conference.
Who should consider this trial
Good fit: Ideal candidates are adult patients hospitalized with COVID-19 who are receiving enoxaparin for DVT prophylaxis.
Not a fit: Patients who are not hospitalized or those not receiving enoxaparin for DVT prophylaxis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimal enoxaparin dosing for preventing thromboembolic events in COVID-19 patients.
How similar studies have performed: Other studies have explored anticoagulation strategies in COVID-19 patients, indicating potential for significant findings, though this specific evaluation is less common.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Richardson, Texas
- Methodist Richardson Medical Center — Richardson, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Betina Daniel, PharmD — Methodist
- Study coordinator: Crystee Cooper, DHEd
- Email: clinicalresearch@mhd.com
- Phone: 214-947-1280
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Venous Thromboembolism