Platelet Activity in Vascular Surgery for Thrombosis and Bleeding

NYU Langone Health200 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Peripheral Vascular Disease Peripheral Artery Disease Carotid Stenosis Aortic Aneurysm, Abdominal Aortic Aneurysm, Thoracic

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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.

Locations (2)

Bellevue Hospital Center, South Manhattan Healthcare Network

New York, New York, United States

New York University School Of Medicine

New York, New York, United States

Outcomes

Primary Outcomes

Platelet Activity

The main outcome measures are platelet activity, coagulation markers, platelet mapping and profiling.

Time frame: two years

Secondary Outcomes

Perioperative Events

Thrombotic and Bleeding events

Time frame: Two-years