Clinical trial NCT01897103: Platelet Activity in Vascular Surgery for Thrombosis and Bleeding
Official title: Platelet Activity in Vascular Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2013-07-11
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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.

Primary outcomes:
measure: Platelet Activity
timeFrame: two years
Secondary outcomes:
measure: Perioperative Events
timeFrame: Two-years
Other outcomes:
Locations:
city: New York
country: United States
facility: Bellevue Hospital Center, South Manhattan Healthcare Network
state: New York
city: New York
country: United States
facility: New York University School Of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jeffrey S Berger, MD, MS, FAHA, FACC
role: PRINCIPAL_INVESTIGATOR
References:
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. No abstract available.
citation: 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.
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.
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.
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.
citation: 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.