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

This study is currently recruiting participants.
Verified January 2014 by New York University School of Medicine
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Jeffrey Berger, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01897103
First received: July 8, 2013
Last updated: January 23, 2014
Last verified: January 2014

July 8, 2013
January 23, 2014
June 2013
December 2014   (final data collection date for primary outcome measure)
Platelet Activity [ Time Frame: two years ] [ Designated as safety issue: No ]
The main outcome measures are platelet activity, coagulation markers, platelet mapping and profiling.
Platelet Activity [ Time Frame: two years ] [ Designated as safety issue: No ]
The main outcome measures are platelet activity, coagulation markers, platelet mapping and profilling.
Complete list of historical versions of study NCT01897103 on ClinicalTrials.gov Archive Site
Perioperative Events [ Time Frame: Two-years ] [ Designated as safety issue: No ]
Thrombotic and Bleeding events
Same as current
Not Provided
Not Provided
 
Platelet Activity in Vascular Surgery for Thrombosis and Bleeding
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

serum, plasma, platelet RNA

Probability Sample

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.

  • Peripheral Vascular Disease
  • Peripheral Artery Disease
  • Carotid Stenosis
  • Aortic Aneurysm, Abdominal
  • Aortic Aneurysm, Thoracic
  • Amputation, Wound
  • Thrombectomy/Embolectomy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
June 2015
December 2014   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
No
Contact: Adriana Perez, MD 305-310-9408 adriana.perez@nyumc.org
Contact: Tammy Seney 212-263-3627 tammy.seney@nyumc.org
United States
 
NCT01897103
S12-03123
No
Jeffrey Berger, New York University School of Medicine
New York University School of Medicine
American Heart Association
Principal Investigator: Jeffrey S Berger, MD, MS, FAHA, FACC New York University School of Medicine
New York University School of Medicine
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP