The purpose of this study is to determine if post-operative administration of intrinsic pathway antagonist (TTP889) in patients on Left Ventricular Assist Device (LVAD) support will result in a 50% reduction of thrombin generation markers at 28 days compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
2
Mount Sinai School of Medicine
New York, New York, United States
New York Presbyterian Hospital / Columbia University Medical Center
New York, New York, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States
The level of thrombin generation markers
Thrombin-antithrombin complex (TAT)and Prothrombin Fragment 1+2 (F1.2)
Time frame: 28 days following initiation of study drug
Thrombin Generation Markers
Time frame: Baseline, Days 1, 3, 5, 7, 14, 21, 28 (±2); and 42 (± 4) days post-randomization
Major Bleeding
Time frame: Day 1 to Day 42 (± 4) days post-randomization
Transfusions of Blood and Blood Products
Time frame: Days 1, 3, 5, 7, 14, 21, 28 (±2); and 42 (± 4) days post-randomization
Blood Count
Time frame: Baseline, Days 1, 3, 5, 7, 14, 21, 28 (±2); and 42 (± 4) days post-randomization
Coagulation Markers
Time frame: Baseline, Days 1, 3, 5, 7, 14, 21, 28 (±2); and 42 (± 4) days post-randomization
Incidence of Serious Adverse Events
Time frame: Baseline, Days 1, 3, 5, 7, 14, 21, 28 (±2); and 42 (± 4) days post-randomization
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