N/A Completed N=20 Randomized Double-blind Treatment

Ventricular Assist Device Anti-Factor Xa (VAD ANTIX) Monitoring Study: a Prospective Randomized Feasibility Trial

Left Sided Heart Failure · Left ventricular assist device · Anticoagulant Therapy · Gastro Intestinal Bleeding

Source: ClinicalTrials.gov NCT03143569 ↗

Enrolled (actual)

Serious AEs

25.0%

Results posted

Feb 2020

Primary outcomePrimary: Nomogram Feasibility — 136; 112; 136; 111 Surveys — p=.45

Summary

This study evaluates two different methods for monitoring a patient's anti-clotting [heparin] therapy after they receive a heart pump implant [left ventricular assist device -LVAD]. One method tests for how long it takes the patient's blood to clot and uses that to determine if they are on the right dose of heparin. The other method uses a more direct measure of how much heparin is in the blood. The hypothesis is that the method that more directly measures how much heparin is in the patient's blood will provide better medical results for the patient's care after they have the heart pump implant. To that end, the investigators are conducting this feasibility trial to establish the logistics associated with the implementation of these heparin monitoring approaches.

Outcome Measures

Outcome	Result	p-value
PRIMARY Nomogram Feasibility	136; 112; 45; 22	.018 sig
PRIMARY Success of Nomogram	39.8; 55.8	—
SECONDARY Nomogram Concordance	242; 166; 138; 223; 36; 27	—
SECONDARY Dosing Changes	4.0; 3.0	—
SECONDARY Time to Therapeutic Dose	48.0; 33.0	—

Eligibility Criteria

Inclusion Criteria

18 years of age and older
Implantation with HeartMate II® or HeartWare®, LVAD at Barnes Jewish Hospital

Exclusion Criteria

Unable to receive heparin-based therapy
Hypercoagulable disorders [factor V Leiden, Antithrombin deficiency, Protein C deficiency, Antiphospholipid antibodies or other thrombophilia]
Incarceration
Pregnancy or breastfeeding

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03143569). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.