Platelet Activity in Vascular Surgery for Thrombosis and Bleeding
|Conditions||peripheral vascular disease, peripheral artery disease, carotid stenosis, aortic aneurysm, abdominal, aortic aneurysm, thoracic, amputation, wound, embolism and thrombosis, aortic aneurysm|
|Sponsor||New York University School of Medicine|
|Collaborator||American Heart Association|
|Start date||June 2013|
|End date||December 2017|
|Trial size||200 participants|
|Trial identifier||NCT01897103, 12-03123|
The proposed PIVOTAL study will examine a panel of platelet/coagulation activity markers during the perioperative period. The goal is to develop a clinically useful assessment of platelet/coagulation activity for risk stratification that may ultimately serve as a target for therapeutic intervention. This study will enroll 200 patients with peripheral artery disease undergoing vascular surgery. PIVOTAL is funded by American Heart Association and is scheduled to begin enrollment in July 2013 for approximately two years.
Recruiting in the following locations…
|United States||New York|
|Other countries||No locations recruiting|
time frame: two years
time frame: Two-years
All participants at least 21 years old.
Inclusion Criteria: - Subjects undergoing non emergent vascular surgery - Use of aspirin within 48 hours prior to surgery - Age > 21 years of age - Able and willing to provide written informed consent for the study Exclusion Criteria: - Use of any anticoagulant (Coumadin, heparin) within 24 hours to surgery - Use of any Nonsteroidal Antiinflammatory Drug (NSAID) (such as ibuprofen, naproxen, etc.) within 72 hours - Thrombocytopenia (platelet count<100) or Thrombocytosis (platelet count>500), - Anemia (hemoglobin<9), - Severe kidney disease (CrCl<30ml/min), - Any known hemorrhagic diathesis.
|Official title||Platelet Activity in Vascular Surgery|
|Principal investigator||Jeffrey S Berger, MD, MS, FAHA, FACC|
|Description||To describe platelet activity among PAD subjects undergoing vascular surgery. To determine whether preoperative platelet activity measurements are independently associated with perioperative cardiovascular events. To identify demographic, clinical, and surgical factors associated with postoperative platelet activity measurements in patients with established PAD.|
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