Platelet Activity in Vascular Surgery for Thrombosis and Bleeding

Completed

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

• Registration Number: NCT01897103
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-07-08
• Study First Submitted QC: 2013-07-08
• Study First Posted: 2013-07-11
• Status Verified: 2017-12
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Last Update Submitted: 2017-12-12
• Last Update Posted: 2017-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Platelet Activity	two years	The main outcome measures are platelet activity, coagulation markers, platelet mapping and profiling.

Secondary Outcome Measures

Name	Time	Method
Perioperative Events	Two-years	Thrombotic and Bleeding events

Trial Locations

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