Inpatient Monitoring of Unfractionated Heparin

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT06329921
Status
Enrolling By Invitation

Conditions

  • Blood Clot
  • Thrombosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PTT protocol — OTHER
    Patients will be monitored using the nurse-managed PTT protocol.
  • anti-Xa protocol — OTHER
    Patients will be monitored using the pharmacy-managed anti-Xa protocol.

Study Details

Unfractionated heparin (UFH) is the most widely used intravenous (IV) anticoagulant for treating and preventing thromboembolic disease (e.g., blood clots ). UFH must be closely monitored and adjusted in the hospital. There are two assays used to monitor UFH: 1) the activated partial thromboplastin time (PTT) and 2) the chromogenic anti-factor Xa assay (anti-Xa). This study aims to compare PTT and anti-Xa methods for monitoring UFH in a pragmatic, randomized controlled trial to determine which helps patients reach a therapeutic anticoagulation range faster.

Key Dates

Start date
Jun 26, 2024
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
700 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Active Comparator: PTT protocol
    Patients randomized to this arm will be monitored using the nurse-managed PTT guided protocol. This includes patients on both high- and low-dose heparin protocols.
  • Active Comparator: Active Comparator: anti-Xa protocol
    Patients randomized to this arm will be monitored using the pharmacy-managed anti-Xa protocol. This includes patients on both high- and low-dose heparin protocols.

Primary Outcome Measure

Time to therapeutic anticoagulation range [ Time Frame: Randomization to hospital discharge at approximately 5-7 days post-randomization ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232-

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