Platelet Reactivity in Patients on a Thienopyridine and Awaiting Coronary Artery Bypass Grafting

NCT01406483 | Completed

• 1 other identifier: Serial CABG
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this exploratory cohort study is to describe levels of platelet reactivity in patients on a thienopyridine awaiting coronary artery bypass grafting (CABG).

Conditions

Complication of Coronary Artery Bypass Graft; Peri-operative Hemorrhage or Hematoma; Post Operative Bleeding

Keywords

Platelet reactivity; CABG; Perioperative and in hospital bleeding

Outcome Measures

Primary Outcomes (2)

• Serial levels of platelet reactivity, as assessed with the Chrono-log Lumi-Aggregometer

  Serial levels of platelet reactivity, as assessed with the Chrono-log Lumi-Aggregometer, which measures levels of light transmittance after stimulation with ADP to estimate levels of platelet aggregation

  Duration of hospital stay; average hospital stay of 1 week

• Perioperative rates of bleeding complications

  Perioperative rates of bleeding complications: 1. need for reoperation because of bleeding 2. need for perioperative red blood cell transfusion (units of packed red blood cells) 3. rates of TIMI, GUSTO, and nuisance bleeding 4. quantity of postoperative drainage (mL)

  Duration of hospital stay; average hospital stay of 1 week

Secondary Outcomes (2)

• Serial levels of platelet reactivity, as assessed with the VerifyNow P2Y12 assay

  Duration of hospital stay; average hospital stay of 1 week

• Serial levels of platelet reactivity, as assessed with the Vasodilator Stimulated Phosphoprotein (VASP) assay

  Duration of hospital stay; average hospital stay of 1 week

Study Arms (1)

CABG

OTHER

Other: Platelet reactivity assessment

Interventions

Platelet reactivity assessment OTHER

Platelet reactivity, as measured by the Chrono-log Lumi-Aggregometer, VerifyNow P2Y12 assay, and Vasodilator Stimulated Phosphoprotein (VASP) flow cytometry assay.

CABG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years old from both genders.
• Taking maintenance thienopyridine therapy within 5 days of surgery OR received a loading dose of thienopyridine therapy within 48 hours of surgery for CABG.
• Referred for CABG (which is scheduled to be performed during the current admission).

You may not qualify if:

• Known allergies to aspirin, clopidogrel, or prasugrel.
• Use of a glycoprotein (GP) IIb/IIIa inhibitor within 8 hours of initial platelet reactivity testing.
• Patient known to be pregnant or lactating.
• Patient with known history of bleeding diathesis or currently active bleeding.
• Platelet count \<100,000/mm the day of initial blood draw.
• Hematocrit \<25% the day of initial blood draw.
• On warfarin therapy at the time of initial blood draw.
• Known blood transfusion within the preceding 10 days of the blood draw.
• Patients treated with non-steroidal anti-inflammatory drugs (NSAIDS) within the previous 5 days.
• Plan for patient to be discharged before undergoing CABG.
• Any significant medical condition that, in the investigator's opinion, may interfere with the patient's optimal participation in the study.

Sponsors & Collaborators

• Medstar Health Research Institute: lead

MeSH Terms

Conditions

Hematoma

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2011
• First Posted: August 1, 2011
• Study Start: August 1, 2010
• Primary Completion: February 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 16, 2021

Record last verified: 2018-06