CompletedNot Applicable

Platelet Activity in Vascular Surgery for Thrombosis and Bleeding

United States200 participantsStarted 2013-06

Plain-language 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.

Who can participate

Age range21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Platelet Activity

Timeframe: two years

Trial details

NCT IDNCT01897103

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-12

View on ClinicalTrials.gov More Peripheral Vascular Disease trials