Gastro Intestinal Bleeding Clinical Trial
— VAD-ANTIXOfficial title:
Ventricular Assist Device Anti-Factor Xa (VAD ANTIX) Monitoring Study: a Prospective Randomized Feasibility Trial
NCT number | NCT03143569 |
Other study ID # | 201701126 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 20, 2017 |
Est. completion date | July 12, 2018 |
Verified date | February 2020 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | July 12, 2018 |
Est. primary completion date | July 12, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. 18 years of age and older 2. Implantation with HeartMate II® or HeartWare®, LVAD at Barnes Jewish Hospital Exclusion Criteria: 1. Unable to receive heparin-based therapy 2. Hypercoagulable disorders [factor V Leiden, Antithrombin deficiency, Protein C deficiency, Antiphospholipid antibodies or other thrombophilia] 3. Incarceration 4. Pregnancy or breastfeeding |
Country | Name | City | State |
---|---|---|---|
United States | Washington University in St Louis School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | Nomogram Feasibility | Questionnaires evaluating pragmatic application of nomograms. Question 3: Overall, I feel that this dosing nomogram is feasible. | 14 days of heparin therapy | |
Primary | 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 | |
Primary | 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 | |
Primary | Success of Nomogram | Amount of time sustained in therapeutic anticoagulation range | 14 days of heparin therapy | |
Secondary | Nomogram Concordance | Compare heparin dosing success between aPTT and anti-factor Xa nomograms. If aPTT was within therapeutic range of nomogram AND anti-factor Xa was within range in therapeutic nomogram, then paired values were deemed "concordent". Similiarly if both aPTT AND anti-factor Xa were above therapeutic range OR both below therapeutic range, then paired valued were deemed "concordent". Otherwise values deemd "discordant" | 14 days of heparin therapy | |
Secondary | Dosing Changes | Number of dosing changes during heparin therapy until first therapeutic | 14 days of heparin therapy | |
Secondary | Time to Therapeutic Dose | Amount of time needed to achieve therapeutic dose from heparin initiation | 14 days of heparin therapy |
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