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Platelet Activity in Vascular Surgery for Thrombosis and Bleeding

NCT ID: NCT01897103

Last Updated: 2017-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey S Berger, MD, MS, FAHA, FACC

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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Bellevue Hospital Center, South Manhattan Healthcare Network

New York, New York, United States

Site Status

New York University School Of Medicine

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22825411 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23223800 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19691485 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22739687 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21562837 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29301628 (View on PubMed)

Other Identifiers

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12-03123

Identifier Type: -

Identifier Source: org_study_id