Platelet Activity in Vascular Surgery for Thrombosis and Bleeding (PIVOTAL)
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.
Peripheral Vascular Disease
Peripheral Artery Disease
Aortic Aneurysm, Abdominal
Aortic Aneurysm, Thoracic
Of Bypass Graft of the Extremities
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Platelet Activity in Vascular Surgery|
- Platelet Activity [ Time Frame: two years ] [ Designated as safety issue: No ]The main outcome measures are platelet activity, coagulation markers, platelet mapping and profilling.
- Perioperative Events [ Time Frame: Two-years ] [ Designated as safety issue: No ]Thrombotic and Bleeding events
Biospecimen Retention: Samples With DNA
serum, plasma, platelet RNA
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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.
|Contact: Adriana Perez, MDemail@example.com|
|United States, New York|
|New York University School Of Medicine||Recruiting|
|New York, New York, United States, 10016|
|Contact: Tammy Seney 212-263-3627 firstname.lastname@example.org|
|Contact: Adriana Perez, MD 305-310-9408 email@example.com|
|Sub-Investigator: Caron Rockman, MD|
|Sub-Investigator: Derya Unutmaz, MD|
|Sub-Investigator: Adriana Perez, MD|
|Sub-Investigator: Jacqueline Bott, RN|
|Principal Investigator:||Jeffrey S Berger, MD, MS, FAHA, FACC||New York University School of Medicine|