Platelet Activity in Vascular Surgery for Thrombosis and Bleeding
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 12/16/2017 |
| Start Date: | June 2013 |
| End Date: | December 2017 |
Platelet Activity in Vascular Surgery
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.
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.
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.
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.
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.
We found this trial at
2
sites
New York, New York 10016
Principal Investigator: Jeffrey Berger, MD, MS, FAHA, FACC
Phone: 646-501-2735
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550 1st Ave
New York, New York 10016
New York, New York 10016
(212) 263-7300
Phone: 646-501-2735
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