PLATelet Function Operating Room Monitoring

Study Overview
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Brief Summary
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Prospective cohort study on adult cardiac surgery patients. Platelet function evaluated before and after cardiopulmonary bypass. Bleeding and transfusion recorded. Primary endpoint is finding the association between postoperative platelet function and bleeding.

Detailed Description
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Preoperative platelet function is a known determinant of postoperative bleeding in cardiac surgery patients (1,2). Conversely, there is a lack of information with respect to postoperative platelet function and postoperative bleeding, and specific cut-off values have not been identified yet. This study will verify the hypothesis that postoperative platelet function is associated with bleeding, and will test the ability of platelet function tests (PFTs) in predicting severe postoperative bleeding. Additional analyses linking platelet function to other preoperative and intraoperative conditions are planned. Patients: Enrollment between February 2017 and January 2018. 800 consecutive adult cardiac surgery patients are considered based on our usual surgical activity. Exclusion criteria: unwillingness to participate, known congenital coagulopathy. Moderate/severe bleeding occurs in about 12% of our patient population. Considering a 15% dropout rate, there are about 80 predicted events. Power analysis: to build a predictive model, at least 60 events of moderate/severe bleeding are required. The study will be stopped at reaching (whatever comes first) 800 enrolled pts; 60 events; or 31st January 2018. Methods: all the patients will receive a preoperative (in the operating room) PFT (ADPtest and TRAPtest) using the aggregometry Multiplate (Roche). The same test will be repeated after protamine administration at the end of CPB. Definitions of bleeding: 12-hours chest drain blood loss; moderate/severe bleeding adjudicated based on the universal definition of perioperative bleeding (3). Statistics: ROC analysis with identification of adequate cut-off values and definition of the PPV and NPV

Official Title
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PLATelet Function Operating Room Monitoring

Conditions
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Bleeding, Platelet Dysfunction Due to Drugs

Intervention / Treatment
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* Device: Platelet function test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cardiac surgery with CPB Exclusion Criteria: Known congenital coagulopathy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Platelet function test|Measurement of P2Y12 and PAR-dependent platelet function activity before and after cardiac surgery by ADPtest and TRAPtest|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative bleeding | Chest drain blood loss | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusions | RBC, FFP, and Platelet concentrate transfusions | 24 hours |