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

NCT03143569 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-02-25

Study results available
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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.

Conditions

  • Left Sided Heart Failure
  • Left Ventricular Assist Device
  • Anticoagulant Therapy
  • Gastro Intestinal Bleeding
  • Thrombosis, LVAD
  • Anti-factor Xa
  • aPTT
  • Heparin

Interventions

DEVICE

aPTT guided heparin management

post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.

DEVICE

Anti-factor Xa guided heparin management

post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Thomas J Graetz, MD · Dept of Anesthesiology, Washington University STL SOM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-20
Primary Completion
2018-07-12
Completion
2018-07-12
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03143569 on ClinicalTrials.gov