Venous ThromboembolismNCT05226793
Medication Use Evaluation for Enoxaparin in Hospitalized COVID-19 Patients
An observational study of Venous Thromboembolism, run by Methodist Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2021to 22 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.)
Who may be able to join
- 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
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- Number of thromboembolic events
- Length of stay
- Readmissions for DVT and/or PE
- In-hospital mortality with associated DVT or PE
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Richardson Medical Center
Richardson, Texas, 75082
About this study
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.
Read the 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.
- Conditions
- Venous Thromboembolism
- Medical subject headings
- Venous Thromboembolism
What is being measured
The primary outcome is the main question the study is designed to answer.
Enoxaparin dose (appropriate for kidney function)
Enoxaparin dose
Measured: 2021-2022
Charlson comorbidity index (CCI) score
(CCI) score
Measured: 2021-2022
Padua prediction score for risk of VTE
Padua prediction score
Measured: 2021-2022
IMPROVE [International Medical Prevention Registry on VTE] bleeding risk assessment score
IMPROVE [International Medical Prevention Registry on VTE] bleeding risk assessment score
Measured: 2021-2022
ICU status
ICU status
Measured: 2021-2022
Number of thromboembolic events
Number of thromboembolic events
Measured: 2021-2022
Length of stay
Days
Measured: 2021-2022
Readmissions for DVT and/or PE
Readmissions for DVT and/or PE
Measured: 2021-2022
In-hospital mortality with associated DVT or PE
In-hospital mortality with associated DVT or PE
Measured: 2021-2022
Secondary outcomes (2)
Bleeding events
Bleeding events
Measured: 2021-2022
Type of bleeding event
Type of bleeding event
Measured: 2021-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start17 Nov 2021
- Primary completion22 Jul 2025
- Study completion22 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Betina Daniel, PharmD, Principal investigator, Methodist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226793
- Sponsor's protocol ID
- 054.PHA.2021.R
- Status last verified
- Jul 2025
- First submitted
- 3 Feb 2022
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Use Evaluation for Enoxaparin in Hospitalized COVID-19 Patients
- ClinicalTrials.gov ID
- NCT05226793
- Acronym / sponsor ID
- 054.PHA.2021.R
- Conditions
- Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 22 Jul 2025 (actual)
- Study completion
- 22 Jul 2025 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.)
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- Safety of intermediate-intensity vs standard prophylactic enoxaparin regimens in patients with COVID-19, measured using the following variables:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Enoxaparin dose (appropriate for kidney function)
Time frame: 2021-2022
Enoxaparin dose
Charlson comorbidity index (CCI) score
Time frame: 2021-2022
(CCI) score
Padua prediction score for risk of VTE
Time frame: 2021-2022
Padua prediction score
IMPROVE [International Medical Prevention Registry on VTE] bleeding risk assessment score
Time frame: 2021-2022
IMPROVE [International Medical Prevention Registry on VTE] bleeding risk assessment score
ICU status
Time frame: 2021-2022
ICU status
Number of thromboembolic events
Time frame: 2021-2022
Number of thromboembolic events
Length of stay
Time frame: 2021-2022
Days
Readmissions for DVT and/or PE
Time frame: 2021-2022
Readmissions for DVT and/or PE
In-hospital mortality with associated DVT or PE
Time frame: 2021-2022
In-hospital mortality with associated DVT or PE
2 secondary outcomes
Bleeding events
Time frame: 2021-2022
Type of bleeding event
Time frame: 2021-2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betina Daniel, PharmD principal investigator
Methodist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enoxaparin dose (appropriate for kidney function) (time frame: 2021-2022). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.