Anticoagulation Clinical Trial
— TRACEOfficial title:
Study of Reduced Anti-coagulation/Anti-platelet Therapy in Patients With the HeartMate II LVAS (TRACE)
NCT number | NCT01477528 |
Other study ID # | TC-081611 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 2011 |
Est. completion date | August 2015 |
Verified date | June 2022 |
Source | Abbott Medical Devices |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 201 |
Est. completion date | August 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Vienna | Vienna | |
Czechia | IKEM | Prague | |
France | Service de Chirurgie Cardiaque | Grenoble | |
France | Hopital Cardiologique | Lille | |
France | Chirurgie Thoracique et Cardiovasculaire Groupe hospitalier Pitie-Salpetriere | Paris | |
France | Hôpital Pontchaillou | Rennes | |
France | Charles Nicolle University Hospital | Rouen | |
Germany | University of Freiburg Medical Center | Freiburg | |
Germany | Medical University Hannover | Hannover | |
United States | University of North Carolina | Chapel Hill | North Carolina |
United States | University of Florida (Shands) | Gainesville | Florida |
United States | Methodist Hospital of Indiana | Indianapolis | Indiana |
United States | St. Vincent Heart Center of Indiana | Indianapolis | Indiana |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Columbia University Medical Center | New York | New York |
United States | Advocate Christ Hospital | Oak Lawn | Illinois |
United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
United States | Sharp Memorial Hospital | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Abbott Medical Devices | Thoratec Europe Ltd |
United States, Austria, Czechia, France, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of thromboembolic events and hemorrhagic events | 24 months |
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