Inpatient Monitoring of Unfractionated Heparin

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Mar 19, 2024

Keywords

ClinConnect Summary

This clinical trial is testing two ways to monitor the blood thinner unfractionated heparin in hospitalized adults to see which method helps reach the target level of anticoagulation faster and safely. It’s being done at Vanderbilt University Medical Center. Participants are randomly assigned to either a nurse-managed PTT-based monitoring plan or a pharmacy-managed anti‑Xa–based monitoring plan. The main question is which method gets patients into the therapeutic range sooner, during the first 5–7 days after randomization. About 2,000 people are expected to enroll, and researchers will follow them through their hospital stay.

If you’re eligible, you must be 18 or older, admitted to Vanderbilt, and have IV heparin ordered with baseline test results in a certain range. People who need extracorporeal membrane oxygenation (ECMO) or have had a cerebrovascular ischemic event are not eligible. If you participate, you’ll be randomly assigned to one monitoring plan and will have regular blood tests to measure how well the heparin is working. The study will look for any new clots, bleeding, or other coagulation problems, typically within the first week after randomization. This trial compares two standard care approaches, not a new drug, and results aren’t available yet.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients at Vanderbilt University Hospital age 18 years and older who are admitted as observation or inpatients for whom intravenous unfractionated heparin (monitored via the PTT nurse-managed protocol) is ordered.
• • Baseline PTT value is ≥0 and ≤ 36.0 seconds
• • Baseline heparin level anti-Xa assay value is ≥0 and ≤0.3
• Exclusion Criteria:
• • Indication for anticoagulation is extracorporeal membrane oxygenation or cerebrovascular ischemic event.
• • Provider determines patient is not appropriate for the study.