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

December 12, 2017 updated by: NYU Langone Health

Platelet Activity in Vascular Surgery

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine
      • New York, New York, United States, 10016
        • Bellevue Hospital Center, South Manhattan Healthcare Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet Activity
Time Frame: two years
The main outcome measures are platelet activity, coagulation markers, platelet mapping and profiling.
two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative Events
Time Frame: Two-years
Thrombotic and Bleeding events
Two-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

American Heart Association

Investigators

  • Principal Investigator: Jeffrey S Berger, MD, MS, FAHA, FACC, NYU Langone Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

July 8, 2013

First Submitted That Met QC Criteria

July 8, 2013

First Posted (Estimate)

July 11, 2013

Study Record Updates

Last Update Posted (Actual)

December 14, 2017

Last Update Submitted That Met QC Criteria

December 12, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-03123

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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