NCT05226793

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 17, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 7, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2025

Completed
Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

3.7 years

First QC Date

February 3, 2022

Last Update Submit

July 23, 2025

Conditions

Outcome Measures

Primary Outcomes (9)

  • Enoxaparin dose (appropriate for kidney function)

    Enoxaparin dose

    2021-2022

  • Charlson comorbidity index (CCI) score

    (CCI) score

    2021-2022

  • Padua prediction score for risk of VTE

    Padua prediction score

    2021-2022

  • IMPROVE [International Medical Prevention Registry on VTE] bleeding risk assessment score

    IMPROVE \[International Medical Prevention Registry on VTE\] bleeding risk assessment score

    2021-2022

  • ICU status

    ICU status

    2021-2022

  • Number of thromboembolic events

    Number of thromboembolic events

    2021-2022

  • Length of stay

    Days

    2021-2022

  • Readmissions for DVT and/or PE

    Readmissions for DVT and/or PE

    2021-2022

  • In-hospital mortality with associated DVT or PE

    In-hospital mortality with associated DVT or PE

    2021-2022

Secondary Outcomes (2)

  • Bleeding events

    2021-2022

  • Type of bleeding event

    2021-2022

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Richardson Medical Center

Richardson, Texas, 75082, United States

Location

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Betina Daniel, PharmD

    Methodist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2022

First Posted

February 7, 2022

Study Start

November 17, 2021

Primary Completion

July 22, 2025

Study Completion

July 22, 2025

Last Updated

July 28, 2025

Record last verified: 2025-07

Locations