Clinical trial NCT01477528: Study of Reduced Anti-coagulation/Anti-platelet Therapy in Patients With the HeartMate II Left Ventricular Assist System (LVAS) (TRACE)
Official title: Study of Reduced Anti-coagulation/Anti-platelet Therapy in Patients With the HeartMate II LVAS (TRACE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anticoagulation
Left Ventricular Assist Device
Keywords: HeartMate II
Anticoagulation
Thoratec Corporation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Thoratec Europe Ltd
First posted: 2011-11-22
Enrollment: 201
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with HeartMate II VAD that are on reduced anticoagulation/antiplatelet regimine

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of thromboembolic events and hemorrhagic events
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Gainesville
country: United States
facility: University of Florida (Shands)
state: Florida
city: Oak Lawn
country: United States
facility: Advocate Christ Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Methodist Hospital of Indiana
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Heart Center of Indiana
state: Indiana
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Prague
country: Czechia
facility: IKEM
city: Grenoble
country: France
facility: Service de Chirurgie Cardiaque
city: Lille
country: France
facility: Hopital Cardiologique
city: Paris
country: France
facility: Chirurgie Thoracique et Cardiovasculaire Groupe hospitalier Pitie-Salpetriere
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Rouen
country: France
facility: Charles Nicolle University Hospital
city: Freiburg
country: Germany
facility: University of Freiburg Medical Center
city: Hannover
country: Germany
facility: Medical University Hannover
Study officials:
affiliation: Thoratec Europe Limited
name: Pooja Chatterjee
role: STUDY_DIRECTOR
affiliation: Thoratec Corporation
name: David Farrar, PhD
role: STUDY_DIRECTOR
References: