Status:
TERMINATED
The Epidemiology of Bleeding and Clotting in Patients Undergoing Heart Transplantation, Coronary Artery Bypass Graft Surgery,or Implantation of Left Ventricular Assist Devices
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Detailed Description
This is a prospective, multi-center, observational study to characterize the epidemiology of bleeding and clotting in patients with underlying systolic ventricular dysfunction undergoing heart transpl...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT01481012
Start Date
January 1 2006
End Date
July 1 2007
Last Update
November 29 2011
Active Locations (13)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Sharp Memorial Hospital
San Diego, California, United States, 92123
3
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
4
Jewish Hospital
Louisville, Kentucky, United States, 40202