Platelet Activity in Vascular Surgery for Thrombosis and Bleeding

Peripheral Artery Disease Clinical Trial

— PIVOTAL  

Official title:

Platelet Activity in Vascular Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01897103
• Other study ID #: 12-03123
• Status: Completed
• Phase: N/A
• First received: July 8, 2013
• Last updated: December 12, 2017
• Start date: June 2013
• Est. completion date: December 2017

Study information

• Verified date: December 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Bellevue Hospital Center, South Manhattan Healthcare Network	New York	New York
United States	New York University School Of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	American Heart Association

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

Berger JS, Hiatt WR. Medical therapy in peripheral artery disease. Circulation. 2012 Jul 24;126(4):491-500. doi: 10.1161/CIRCULATIONAHA.111.033886. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet Activity	The main outcome measures are platelet activity, coagulation markers, platelet mapping and profiling.	two years
Secondary	Perioperative Events	Thrombotic and Bleeding events	Two-years