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Platelet Activity in Vascular Surgery for Thrombosis and Bleeding (PIVOTAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01897103
Recruitment Status : Completed
First Posted : July 11, 2013
Last Update Posted : December 14, 2017
American Heart Association
Information provided by (Responsible Party):
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.

Condition or disease
Peripheral Vascular Disease Peripheral Artery Disease Carotid Stenosis Aortic Aneurysm, Abdominal Aortic Aneurysm, Thoracic Amputation, Wound Embolism and Thrombosis Aortic Aneurysm

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.

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Platelet Activity in Vascular Surgery
Study Start Date : June 2013
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Platelet Activity [ Time Frame: two years ]
    The main outcome measures are platelet activity, coagulation markers, platelet mapping and profiling.

Secondary Outcome Measures :
  1. Perioperative Events [ Time Frame: Two-years ]
    Thrombotic and Bleeding events

Biospecimen Retention:   Samples With DNA
serum, plasma, platelet RNA

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Study Population will be selected from the inpatient setting at NYU Medical Center and Bellevue Hospital as well as the outpatient setting in the Faculty Group Practice.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01897103

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United States, New York
Bellevue Hospital Center, South Manhattan Healthcare Network
New York, New York, United States, 10016
New York University School Of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
American Heart Association
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Principal Investigator: Jeffrey S Berger, MD, MS, FAHA, FACC NYU Langone Health
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: NYU Langone Health Identifier: NCT01897103    
Other Study ID Numbers: 12-03123
First Posted: July 11, 2013    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Peripheral Artery Disease
Endarterectomy (Carotid)
Aortic Aneurysm, Abdominal
Aortic Aneurysm, Thoracic
Platelet Activity
Additional relevant MeSH terms:
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Carotid Stenosis
Aortic Aneurysm
Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Aortic Aneurysm, Abdominal
Embolism and Thrombosis
Aortic Aneurysm, Thoracic
Cardiovascular Diseases
Aortic Diseases
Arterial Occlusive Diseases
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases