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

NCT03143569 | Completed Results FDA Device

• 1 other identifier: 201701126
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• Nomogram Feasibility

  Questionnaires evaluating pragmatic application of nomograms. Question 1: The current heparin nomogram using (aPTT or anti-Xa depending on group) monitoring is easy to follow.

  14 days of heparin therapy

• Nomogram Feasibility

  Questionnaires evaluating pragmatic application of nomograms. Question 2: Overall, I am satisfied with the utilization and implementation of the heparin monitoring nomogram.

  14 days of heparin therapy

• Nomogram Feasibility

  Questionnaires evaluating pragmatic application of nomograms. Question 3: Overall, I feel that this dosing nomogram is feasible.

  14 days of heparin therapy

• Nomogram Feasibility

  Questionnaires evaluating pragmatic application of nomograms. Question 4: When my patient is on the heparin nomogram, I follow the dosing and monitoring instructions exactly.

  14 days of heparin therapy

• Nomogram Feasibility

  Questionnaires evaluating pragmatic application of nomograms. Question 5: I often had to seek clarification from a coworker, pharmacist, NP, or MD regarding the nomogram instructions.

  14 days of heparin therapy

• Success of Nomogram

  Amount of time sustained in therapeutic anticoagulation range

  14 days of heparin therapy

Secondary Outcomes (3)

• Nomogram Concordance

  14 days of heparin therapy

• Dosing Changes

  14 days of heparin therapy

• Time to Therapeutic Dose

  14 days of heparin therapy

Study Arms (2)

aPTT nomogram

ACTIVE COMPARATOR

aPTT guided heparin management

Device: aPTT guided heparin management; Device: Anti-factor Xa guided heparin management

Anti-factor Xa nomogram

EXPERIMENTAL

Anti-factor Xa guided heparin management

Device: aPTT guided heparin management; Device: Anti-factor Xa guided heparin management

Interventions

aPTT guided heparin management DEVICE

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

Anti-factor Xa nomogram; aPTT nomogram

Anti-factor Xa guided heparin management DEVICE

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

Anti-factor Xa nomogram; aPTT nomogram

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St Louis School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Heart Failure; Gastrointestinal Hemorrhage; Thrombosis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases

Results Point of Contact

• Title: Thomas J Graetz
• Organization: WASHINGTON UNIVERSITY

graetzt@wustl.edu

3147474155

Study Officials

• Thomas J Graetz, MD

  Dept of Anesthesiology, Washington University STL SOM

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof of Anesthesiology

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: May 8, 2017
• Study Start: May 20, 2017
• Primary Completion: July 12, 2018
• Study Completion: July 12, 2018
• Last Updated: February 25, 2020
• Results First Posted: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)