AnticoagulationTRACENCT01477528
Study of Reduced Anti-coagulation/Anti-platelet Therapy in Patients With the HeartMate II Left Ventricular Assist System (LVAS) (TRACE)
An observational study of Anticoagulation and Left Ventricular Assist Device, run by Abbott Medical Devices at 18 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anticoagulation, Left Ventricular Assist Device
- How many people
- 201 participants
- Where
- 18 sitesin 5 countries
- Study dates
- Nov 2011to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with HeartMate II VAD that are on reduced anticoagulation/antiplatelet regimine
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
18 sites in 5 countries.
18 sites in 5 countries
United States9 sites
University of North Carolina
Chapel Hill, North Carolina, 27599
University of Florida (Shands)
Gainesville, Florida, 32610
Methodist Hospital of Indiana
Indianapolis, Indiana, 46202
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, 46260
University of Minnesota
Minneapolis, Minnesota, 55455
Columbia University Medical Center
New York, New York, 10032
Advocate Christ Hospital
Oak Lawn, Illinois, 60453
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Sharp Memorial Hospital
San Diego, California, 92123
France5 sites
Service de Chirurgie Cardiaque
Grenoble
Hopital Cardiologique
Lille
Chirurgie Thoracique et Cardiovasculaire Groupe hospitalier Pitie-Salpetriere
Paris
Hôpital Pontchaillou
Rennes
Charles Nicolle University Hospital
Rouen
Germany2 sites
University of Freiburg Medical Center
Freiburg im Breisgau
Medical University Hannover
Hanover
About this study
Official title: 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.
- Conditions
- Anticoagulation, Left Ventricular Assist Device
- Keywords
- HeartMate II, Anticoagulation, Thoratec Corporation
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of thromboembolic events and hemorrhagic events
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnticoagulationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Thoratec Europe Ltd
- Responsible party
- Sponsor
- Investigators
- Pooja Chatterjee, Study director, Thoratec Europe LimitedDavid Farrar, PhD, Study director, Thoratec Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477528
- Sponsor's protocol ID
- TC-081611
- Acronym
- TRACE
- Status last verified
- Jun 2022
- First submitted
- 17 Nov 2011
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Reduced Anti-coagulation/Anti-platelet Therapy in Patients With the HeartMate II LVAS (TRACE)
- ClinicalTrials.gov ID
- NCT01477528
- Acronym / sponsor ID
- TRACE / TC-081611
- Conditions
- Anticoagulation, Left Ventricular Assist Device
- Keywords
- HeartMate II, Anticoagulation, Thoratec Corporation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Thoratec Europe Ltd
- Study start
- Nov 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with HeartMate II VAD that are on reduced anticoagulation/antiplatelet regimine
Key inclusion criteria (7 listed)
- 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:
- OR
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of thromboembolic events and hemorrhagic events
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pooja Chatterjee study director
Thoratec Europe Limited
David Farrar, PhD study director
Thoratec Corporation
18 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anticoagulation and Left Ventricular Assist Device, run by Abbott Medical Devices at 18 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, France, Germany, Austria, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of thromboembolic events and hemorrhagic events (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.