The Epidemiology of Bleeding and Clotting in Patients Undergoing Heart Transplantation, Coronary Artery Bypass Graft Surgery,or Implantation of Left Ventricular Assist Devices
Stopped early
Conditions studied: Congestive Heart Failure
In brief
The purpose of this study is to obtain data or information on how blood clotting factors are activated during open heart surgery. In particular, the investigators are interested in how blood clotting factors are activated by the heart-lung bypass machine and by left ventricular assist devices (LVAD). Patients on these two machines have an increased risk of bleeding and blood clot formation. This is because both machines stimulate the intrinsic coagulation pathway, one of the chemical pathways that cause blood to clot. The process of surgery itself also stimulates the "extrinsic coagulation pathway," the other chemical pathway that causes blood to clot. Stimulating these coagulation pathways can use up the body's clotting factors. As a result, patients may be at risk for both bleeding and blood clot formation. The investigators would like to study how the blood factors are activated during and after surgery, to help develop treatments to prevent bleeding and clot formation.
Key facts
- Study ID
- NCT01481012
- Run by
- Icahn School of Medicine at Mount Sinai
- People needed
- 94
- Starts
- 2006-01-01
- Expected to finish
- 2007-07-01
- Last updated by the study team
- 2011-11-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Signed informed consent, release of medical information, and HIPAA forms;
- Age greater than or equal to 18 years;
- Male, postmenopausal female, or female who may become pregnant but is using adequate contraceptive precautions (defined as oral contraceptive, intrauterine devices, surgical contraception or a combination of a condom and a spermicide), with negative pregnancy test;
- Admitted to the clinical center at the time of enrollment;
- Approved and scheduled to undergo one of the following within 24 hours of enrollment:
- Orthotopic heart transplantation
- CABG and/or valve surgery on CPB; these patients must have an LV ejection fraction of ≤35%
- Implantation of a pulsatile LVAD (e.g.Thoratec HeartMate® I LVAD) for destination therapy or bridge to transplantation
- Implantation of a continuous flow LVAD (e.g. HeartMate® II, DeBakey VAD® or VentrAssist® LVAS) for destination therapy or bridge to transplantation
You may not qualify if…
- History of a platelet disorder;
- History of a known, or an inherited, or an acquired coagulation disorder in the study subject;
- Stroke within 30 days prior to enrollment;
- Allergy to heparin or protamine;
- Participation in a clinical investigational intervention trial, with the exception of an investigational VAD trial, at the time of enrollment;
- Received investigational intervention within 30 days of enrollment, with the exception of an investigational VAD trial
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- Sharp Memorial Hospital — San Diego, California, United States
- Advocate Christ Medical Center — Oak Lawn, Illinois, United States
- Jewish Hospital — Louisville, Kentucky, United States
- University of Michigan — Ann Arbor, Michigan, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- Columbia Presbyterian Medical Center — New York, New York, United States
- Montefiore Medical Center — The Bronx, New York, United States
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
- LDS Hospital — Salt Lake City, Utah, United States
- Sacred Heart Medical Center — Spokane, Washington, United States
- University of Wisconsin Hospital — Madison, Wisconsin, United States
- St. Luke's Medical Center — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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