Platelet Activity in Vascular Surgery for Thrombosis and Bleeding

NCT01897103 | Completed

• 1 other identifier: 12-03123
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Peripheral Artery Disease; Endarterectomy (Carotid); Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracic; Amputation; Platelet Activity; Thrombin; Transcriptomics

Outcome Measures

Primary Outcomes (1)

• Platelet Activity

  The main outcome measures are platelet activity, coagulation markers, platelet mapping and profiling.

  two years

Secondary Outcomes (1)

• Perioperative Events

  Two-years

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• American Heart Association: collaborator

Study Sites (2)

Bellevue Hospital Center, South Manhattan Healthcare Network

New York, New York, 10016, United States

Location

New York University School Of Medicine

New York, New York, 10016, United States

Location

Related Publications (6)

• Berger JS, Hiatt WR. Medical therapy in peripheral artery disease. Circulation. 2012 Jul 24;126(4):491-500. doi: 10.1161/CIRCULATIONAHA.111.033886. No abstract available.

  PMID: 22825411 BACKGROUND

• Berger JS, Becker RC, Kuhn C, Helms MJ, Ortel TL, Williams R. Hyperreactive platelet phenotypes: relationship to altered serotonin transporter number, transport kinetics and intrinsic response to adrenergic co-stimulation. Thromb Haemost. 2013 Jan;109(1):85-92. doi: 10.1160/TH12-03-0202. Epub 2012 Dec 6.

  PMID: 23223800 BACKGROUND

• Chu SG, Becker RC, Berger PB, Bhatt DL, Eikelboom JW, Konkle B, Mohler ER, Reilly MP, Berger JS. Mean platelet volume as a predictor of cardiovascular risk: a systematic review and meta-analysis. J Thromb Haemost. 2010 Jan;8(1):148-56. doi: 10.1111/j.1538-7836.2009.03584.x. Epub 2009 Aug 19.

  PMID: 19691485 BACKGROUND

• Eraso LH, Fukaya E, Mohler ER 3rd, Xie D, Sha D, Berger JS. Peripheral arterial disease, prevalence and cumulative risk factor profile analysis. Eur J Prev Cardiol. 2014 Jun;21(6):704-11. doi: 10.1177/2047487312452968. Epub 2012 Jun 27.

  PMID: 22739687 BACKGROUND

• Sharma G, Berger JS. Platelet activity and cardiovascular risk in apparently healthy individuals: a review of the data. J Thromb Thrombolysis. 2011 Aug;32(2):201-8. doi: 10.1007/s11239-011-0590-9.

  PMID: 21562837 BACKGROUND

• Dann R, Hadi T, Montenont E, Boytard L, Alebrahim D, Feinstein J, Allen N, Simon R, Barone K, Uryu K, Guo Y, Rockman C, Ramkhelawon B, Berger JS. Platelet-Derived MRP-14 Induces Monocyte Activation in Patients With Symptomatic Peripheral Artery Disease. J Am Coll Cardiol. 2018 Jan 2;71(1):53-65. doi: 10.1016/j.jacc.2017.10.072.

  PMID: 29301628 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, platelet RNA

MeSH Terms

Conditions

Peripheral Vascular Diseases; Peripheral Arterial Disease; Carotid Stenosis; Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracic; Wounds and Injuries; Embolism and Thrombosis; Aortic Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Aortic Diseases

Study Officials

• Jeffrey S Berger, MD, MS, FAHA, FACC

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: July 11, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 14, 2017

Record last verified: 2017-12

Locations

US (2)