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Platelets as Regulators of Inflammation in Cardiac Surgery (PRICS)

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ClinicalTrials.gov Identifier: NCT02568410
Recruitment Status : Completed
First Posted : October 5, 2015
Last Update Posted : May 23, 2019
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Duke University

Brief Summary:

Platelets are increasingly recognized as a potent and ubiquitously present source of inflammatory activation. Importantly, antiplatelet therapy has been shown to significantly reduce major adverse events such as renal injury in cardiac surgery patients. However, in current practice, concerns of excessive bleeding-not platelet activation and thrombosis-shape clinical decisions.

The investigators have recently seen, that a significant drop in platelet numbers following cardiac surgery is associated with increased mortality and risk of acute kidney injury. The investigators hypothesize that such thrombocytopenia is a result of excessive perioperative platelet activation and resultant release of inflammatory and tissue injurious signals by activated platelets. Platelet activation will be characterized during and after cardiac surgery and examine its correlation with inflammatory responses and perioperative end-organ injury.


Condition or disease Intervention/treatment
Systemic Inflammatory Response Syndrome Acute Kidney Injury Procedure: coronary artery bypass grafting using cardiopulmonary bypass

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Study Type : Observational
Actual Enrollment : 99 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Platelets as Regulators of Inflammation and Tissue Injury After Cardiac Surgery
Study Start Date : October 2015
Actual Primary Completion Date : May 2019
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
CABG on CPB
Patients undergoing elective coronary artery bypass grafting using cardiopulmonary bypass. No study interventions beyond the standard clinical practice for these surgeries at Duke University Medical Center. No study drug administration.
Procedure: coronary artery bypass grafting using cardiopulmonary bypass
no study intervention. Study cohort will undergo coronary artery bypass grafting using cardiopulmonary bypass according to standard practices at DUMC




Primary Outcome Measures :
  1. Acute kidney injury [ Time Frame: 30 days ]
    AKI according to KDIGO criteria


Secondary Outcome Measures :
  1. systemic inflammatory response activation, as measured by serum TNFa levels [ Time Frame: perioperative ]
    serum measurement of inflammatory markers

  2. systemic inflammatory response activation, as measured by serum IL8 levels [ Time Frame: perioperative ]
    serum measurement of inflammatory markers

  3. systemic inflammatory response activation, as measured by serum Chymase levels [ Time Frame: perioperative ]
    serum measurement of inflammatory markers

  4. systemic inflammatory response activation, as measured by serum IL6 levels [ Time Frame: perioperative ]
    serum measurement of inflammatory markers

  5. platelet activation, as measured by p-selection levels [ Time Frame: perioperative ]
    p-selectin, serum platelet factor 4

  6. platelet activation, as measured by serum platelet factor 4 levels [ Time Frame: perioperative ]
    p-selectin, serum platelet factor 4

  7. hospital length of stay [ Time Frame: 30-days ]
  8. Intensive care unit length of stay [ Time Frame: 30-day ]
  9. major adverse cardiac events [ Time Frame: 30-day ]
    all-cause mortality, emergent revascularization, atrial fibrillation, stroke, and non-fatal myocardial infarction


Biospecimen Retention:   Samples With DNA
Plasma, DNA, Platelet RNA


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients undergoing elective coronary artery bypass grafting
Criteria

Inclusion Criteria:

  • all patients undergoing elective CABG procedures

Exclusion Criteria:

  • patients with a history of:

    • renal injury (creatinine > 1.5 mg/dL)
    • hepatic insufficiency (liver function tests > 1.5 times the upper limit of normal),
    • severe pulmonary insufficiency (requiring home oxygen therapy),
    • EF < 20%,
    • IABP use preoperatively,
    • liver, heart, or lung transplant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568410


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
American Heart Association
Investigators
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Principal Investigator: jorn karhausen, md Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02568410    
Other Study ID Numbers: Pro00064249
First Posted: October 5, 2015    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: June 2018
Keywords provided by Duke University:
Mast Cells
Blood Platelets
cardiac surgical procedures
Additional relevant MeSH terms:
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Acute Kidney Injury
Inflammation
Systemic Inflammatory Response Syndrome
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Shock