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

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ClinicalTrials.gov Identifier: NCT01897103
Recruitment Status : Completed
First Posted : July 11, 2013
Last Update Posted : December 14, 2017
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
New York University School of Medicine

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.


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
Primary Completion Date : December 2017
Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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


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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01897103


Locations
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
New York University School of Medicine
American Heart Association
Investigators
Principal Investigator: Jeffrey S Berger, MD, MS, FAHA, FACC New York University School of Medicine

Publications:
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01897103     History of Changes
Other Study ID Numbers: 12-03123
First Posted: July 11, 2013    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by New York University School of Medicine:
Peripheral Artery Disease
Endarterectomy (Carotid)
Aortic Aneurysm, Abdominal
Aortic Aneurysm, Thoracic
Amputation
Platelet Activity
Thrombin
Transcriptomics

Additional relevant MeSH terms:
Aneurysm
Thrombosis
Embolism
Aortic Aneurysm
Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Carotid Stenosis
Aortic Aneurysm, Abdominal
Embolism and Thrombosis
Aortic Aneurysm, Thoracic
Cardiovascular Diseases
Aortic Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases