N/A
N=20
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 · Thrombosis, LVAD
Bottom Line
View on ClinicalTrials.gov: NCT03143569 ↗Enrolled (actual)
20
Serious AEs
25.0%
Results posted
Feb 2020
Primary outcome: Primary: Nomogram Feasibility — 136; 112; 136; 111 Surveys — p=.45
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- aPTT guided heparin management (Device); Anti-factor Xa guided heparin management (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nomogram Feasibility |
136; 112; 45; 22 | .018 sig |
| PRIMARY Nomogram Feasibility |
136; 112; 45; 22 | .018 sig |
| PRIMARY Nomogram Feasibility |
136; 112; 45; 22 | .018 sig |
| PRIMARY Nomogram Feasibility |
136; 112; 45; 22 | .018 sig |
| 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 | — |
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.
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
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.