Study of Reduced Anti-coagulation/Anti-platelet Therapy in Patients With the HeartMate II Left Ventricular Assist System (LVAS) (TRACE)



Status:Completed
Healthy:No
Age Range:Any
Updated:2/1/2019
Start Date:November 2011
End Date:August 2015

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Study of Reduced Anti-coagulation/Anti-platelet Therapy in Patients With the HeartMate II LVAS (TRACE)

The purpose of this observational study is to obtain multi-center data on HeartMate II (HMII)
patients managed with reduced anticoagulation or anti-platelet regimes, and the incidence of
thrombotic and bleeding adverse events associated with these regimes.


Inclusion Criteria:

- HeartMate II Left Ventricular Assist Device (LVAD) patient

- Patient has signed an informed consent for data collection.

- Patient was discharged, or is being discharged, from the hospital after their initial
LVAD implant surgery.

- Patient:

- at time of enrolling in study, is currently on, with the intention of being
maintained on reduced anti-thrombotic therapy (RT) for chronic long-term
management.

OR

-- On or after January 1, 2011 patient was being maintained on, or had been initiated with
the intention of being maintained on, reduced anti-thrombotic therapy (RT) for chronic
long-term management; but where RT was subsequently discontinued due to an adverse event or
transplant, explant, or death.

Exclusion Criteria:

- Patients under acute management of anti-thrombotic agents before a final decision on
long term antithrombotic strategy.

- Patients requiring a legal representative to sign consent form, rather than
themselves.

- Patient is being managed on other anti-thrombotic agents
We found this trial at
10
sites
320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Gainesville, Florida 32611
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Minneapolis, MN
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Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Chapel Hill, NC
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Indianapolis, Indiana 46260
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Indianapolis, IN
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Indianapolis, Indiana 46202
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Oak Lawn, Illinois 60453
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Oak Lawn, IL
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7901 Frost Street
San Diego, California 92123
858-939-3400
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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San Diego, CA
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Vienna,
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