Platelet Activity in Vascular Surgery for Thrombosis and Bleeding

Platelet Activity in Vascular Surgery

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01897103

Acronym

PIVOTAL

Enrollment

200

Registered

2013-07-11

Start date

2013-06-30

Completion date

2017-12-31

Last updated

2017-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Platelet Activity	two years	The main outcome measures are platelet activity, coagulation markers, platelet mapping and profiling.

Secondary

Measure	Time frame	Description
Perioperative Events	Two-years	Thrombotic and Bleeding events

Countries

United States

Outcome results