Platelet Activity in Vascular Surgery for Thrombosis and Bleeding

Completed

Conditions studied: Peripheral Vascular Disease, Peripheral Artery Disease, Carotid Stenosis, Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracic, Amputation, Wound, Embolism and Thrombosis, Aortic Aneurysm

In brief

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.

Key facts

Study ID: NCT01897103
Run by: NYU Langone Health
People needed: 200
Starts: 2013-06-01
Expected to finish: 2017-12-01
Last updated by the study team: 2017-12-14

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

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

Full record on ClinicalTrials.gov

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