Platelet Activity in Vascular Surgery for Thrombosis and Bleeding

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.

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Key information

Conditions

Peripheral Vascular Disease Amputation, Wound Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Aneurysm, Thoracic Aortic Diseases Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Embolism and Thrombosis Nervous System Diseases Peripheral Arterial Disease Peripheral Artery Disease Peripheral Vascular Diseases Vascular Diseases Wounds and Injuries

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bellevue Hospital Center, South Manhattan Healthcare Network, New York, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Platelet Activity

Time frame: two years

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

Secondary outcomes

Perioperative Events

Time frame: Two-years

Thrombotic and Bleeding events

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

American Heart Association

Registry information

Official study title

Platelet Activity in Vascular Surgery

Acronym: PIVOTAL

Important dates

Study start: 2013
Primary completion: 2017
Study completion: 2017
First posted: Jul 11, 2013
Registry last updated: Dec 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed