Ventricular Assist Device Anti-Factor Xa (VAD ANTIX) Monitoring Study: a Prospective Randomized Feasibility Trial
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Cardiology, Gastrointestinal |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/13/2019 |
| Start Date: | May 20, 2017 |
| End Date: | July 12, 2018 |
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.
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.
Heart failure is a medical condition that is on the rise in the US and is associated with an
enormous cost of $30 billion in healthcare expenses. People with heart failure may be treated
with an LVAD that is connected to their heart and helps it pump the blood from the left side
of the heart into the blood vessels that delivers blood to the body. These devices can be
used to treat heart failure for the long term or they can be used while a patient waits for a
heart transplant. In either case, the use of these devices is increasing.
One of the primary risks associated with LVADs are those related to blood clotting.
Maintenance of the LVAD depends on preventing blood clots especially right after the surgery
that puts them in place. This requires putting patients with LVADs on blood thinners and then
monitoring the blood thinner levels carefully so that they don't have problems with bleeding
too easily or, on the other hand, forming blood clots if they aren't on the right dose of
blood thinners. Excessive bleeding - called hemorrhaging - is the more common problem after
surgery and half of all patients that receive an LVAD will require a blood transfusion within
the first 30 days after they receive the device. A laboratory test that measures how quickly
blood clots is used to determine if the patient has the right amount of blood thinners. The
current standard test is called "activated partial thromboplastin time [aPTT]." There are
problems with the reliability of this test because it reacts with other elements in the
blood. Alternately, there is a test that more directly measures the amount of heparin blood
thinner rather than coagulation time and may be more reliable than aPTT called anti-factor Xa
[anti-Xa].
The investigators have developed process diagrams that show steps for making decisions
[called nomograms] that tell a nurse or doctor how to manage the heparin levels using test
results from the aPTT test or the anti-Xa test; however, both tests will be performed at each
decision time point, but the care team will only be told the results from the testing to
which their patient is assigned.
The purpose of this feasibility study is to establish feasibility of using the two nomograms
to determine which provides the optimal clinical information for improving patients' outcomes
that have had LVADs placed.
Potential subjects will be recruited prior to their surgery and may decline to participate
anytime before or after the surgery takes place. Subjects will be randomized to the aPTT
nomogram or the anti-Xa nomogram. If they withdraw consent, they will receive the aPTT
standard of care monitoring. The study procedures are performed by the clinical care team.
Clinicians will be trained to use the nomograms.
enormous cost of $30 billion in healthcare expenses. People with heart failure may be treated
with an LVAD that is connected to their heart and helps it pump the blood from the left side
of the heart into the blood vessels that delivers blood to the body. These devices can be
used to treat heart failure for the long term or they can be used while a patient waits for a
heart transplant. In either case, the use of these devices is increasing.
One of the primary risks associated with LVADs are those related to blood clotting.
Maintenance of the LVAD depends on preventing blood clots especially right after the surgery
that puts them in place. This requires putting patients with LVADs on blood thinners and then
monitoring the blood thinner levels carefully so that they don't have problems with bleeding
too easily or, on the other hand, forming blood clots if they aren't on the right dose of
blood thinners. Excessive bleeding - called hemorrhaging - is the more common problem after
surgery and half of all patients that receive an LVAD will require a blood transfusion within
the first 30 days after they receive the device. A laboratory test that measures how quickly
blood clots is used to determine if the patient has the right amount of blood thinners. The
current standard test is called "activated partial thromboplastin time [aPTT]." There are
problems with the reliability of this test because it reacts with other elements in the
blood. Alternately, there is a test that more directly measures the amount of heparin blood
thinner rather than coagulation time and may be more reliable than aPTT called anti-factor Xa
[anti-Xa].
The investigators have developed process diagrams that show steps for making decisions
[called nomograms] that tell a nurse or doctor how to manage the heparin levels using test
results from the aPTT test or the anti-Xa test; however, both tests will be performed at each
decision time point, but the care team will only be told the results from the testing to
which their patient is assigned.
The purpose of this feasibility study is to establish feasibility of using the two nomograms
to determine which provides the optimal clinical information for improving patients' outcomes
that have had LVADs placed.
Potential subjects will be recruited prior to their surgery and may decline to participate
anytime before or after the surgery takes place. Subjects will be randomized to the aPTT
nomogram or the anti-Xa nomogram. If they withdraw consent, they will receive the aPTT
standard of care monitoring. The study procedures are performed by the clinical care team.
Clinicians will be trained to use the nomograms.
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
We found this trial at
1
site
Saint Louis, Missouri 63110
Phone: 314-362-1196
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