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

Unfractionated Heparin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06096064
• Other study ID #: 100.PHA.2022.R
• Status: Completed
• Start date: October 31, 2022
• Est. completion date: August 21, 2023

Study information

• Verified date: September 2022
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 21, 2023
• Est. primary completion date: August 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Unfractionated Heparin

Locations

Country	Name	City	State
United States	Methodist Richardson Medical Center	Dallas	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	Incidents of deviations from protocol	Appropriate anticoagulation management will be measured using Percent time in therapeutic range based on aPTT levels	30 Days