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 |
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.
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
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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