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Medication Use Evaluation (MUE) for Continuous Heparin Infusions in Hospitalized Patients

Sponsor
Methodist Health System (Other)
Overall Status
Completed
CT.gov ID
NCT06096064
Collaborator
(none)
100
Enrollment
1
Location
9.7
Actual Duration (Months)
10.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Unfractionated heparin (UFH) is an anticoagulant to prevent thrombus formation or worsening of an existing thrombus. It is indicated for patients with deep vein thrombosis/pulmonary embolism (DVT/PE) or acute coronary syndrome (ACS). Unfractionated heparin treatment consists of an initial bolus followed by a continuous infusion that is adjusted based on the patient's subsequent partial thromboplastin time (PTT) levels

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Unfractionated heparin is classified as a high-alert medication in the acute care setting.3 Therapeutic anticoagulation is a high priority for healthcare teams because the impacts of inadequate anticoagulation can lead to life threatening events such as a major bleed or thrombus formation and/or death.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    100 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Medication Use Evaluation (MUE) for Continuous Heparin Infusions in Hospitalized Patients
    Actual Study Start Date :
    Oct 31, 2022
    Actual Primary Completion Date :
    Aug 21, 2023
    Actual Study Completion Date :
    Aug 21, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Incidents of deviations from protocol [30 Days]

      Appropriate anticoagulation management will be measured using Percent time in therapeutic range based on aPTT levels

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient's aged 18 years or older with a confirmed diagnosis of DVT/PE based on imaging or a confirmed diagnosis of ACS requiring heparin therapy
    Exclusion Criteria:

    • History of bleeding in the last 30 days

    • History of HIT

    • Use of systemic anticoagulants for another indication

    • Presence of coagulation disorder prior to admission (i.e. hemophilia, sickle cell anemia, etc.)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Methodist Richardson Medical Center Dallas Texas United States 75082

    Sponsors and Collaborators

    • Methodist Health System

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Methodist Health System
    ClinicalTrials.gov Identifier:
    NCT06096064
    Other Study ID Numbers:
    • 100.PHA.2022.R
    First Posted:
    Oct 23, 2023
    Last Update Posted:
    Oct 23, 2023
    Last Verified:
    Sep 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 23, 2023