Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01897103
First received: July 8, 2013
Last updated: April 13, 2016
Last verified: April 2016
  Purpose
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
Peripheral Vascular Disease
Peripheral Artery Disease
Carotid Stenosis
Aortic Aneurysm, Abdominal
Aortic Aneurysm, Thoracic
Amputation, Wound
Embolism and Thrombosis
Aortic Aneurysm

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Platelet Activity in Vascular Surgery

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Platelet Activity [ Time Frame: two years ] [ Designated as safety issue: No ]
    The main outcome measures are platelet activity, coagulation markers, platelet mapping and profiling.


Secondary Outcome Measures:
  • Perioperative Events [ Time Frame: Two-years ] [ Designated as safety issue: No ]
    Thrombotic and Bleeding events


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

Enrollment: 200
Study Start Date: June 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01897103     History of Changes
Other Study ID Numbers: 12-03123 
Study First Received: July 8, 2013
Last Updated: April 13, 2016
Health Authority: United States: Institutional Review Board

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
Vascular Diseases
Aortic Aneurysm
Peripheral Vascular Diseases
Peripheral Arterial Disease
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

ClinicalTrials.gov processed this record on September 23, 2016