Study Results
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Basic Information
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COMPLETED
490 participants
OBSERVATIONAL
2017-02-01
2018-03-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Platelet function test
Measurement of P2Y12 and PAR-dependent platelet function activity before and after cardiac surgery by ADPtest and TRAPtest
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
95 Years
ALL
No
Sponsors
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IRCCS Policlinico S. Donato
OTHER
Responsible Party
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Marco Ranucci
Head of Cardiothoracic Anesthesia and ICU depy
Principal Investigators
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Marco Ranucci, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Policlinico S. Donato
Locations
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IRCCS Policlinico San Donato
San Donato Milanese, Milan, Italy
Countries
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References
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Ranucci M, Baryshnikova E, Soro G, Ballotta A, De Benedetti D, Conti D; Surgical and Clinical Outcome Research (SCORE) Group. Multiple electrode whole-blood aggregometry and bleeding in cardiac surgery patients receiving thienopyridines. Ann Thorac Surg. 2011 Jan;91(1):123-9. doi: 10.1016/j.athoracsur.2010.09.022.
Ranucci M, Colella D, Baryshnikova E, Di Dedda U; Surgical and Clinical Outcome Research (SCORE) Group. Effect of preoperative P2Y12 and thrombin platelet receptor inhibition on bleeding after cardiac surgery. Br J Anaesth. 2014 Dec;113(6):970-6. doi: 10.1093/bja/aeu315. Epub 2014 Sep 10.
Dyke C, Aronson S, Dietrich W, Hofmann A, Karkouti K, Levi M, Murphy GJ, Sellke FW, Shore-Lesserson L, von Heymann C, Ranucci M. Universal definition of perioperative bleeding in adult cardiac surgery. J Thorac Cardiovasc Surg. 2014 May;147(5):1458-1463.e1. doi: 10.1016/j.jtcvs.2013.10.070. Epub 2013 Dec 9.
Other Identifiers
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PlateletMonitoring
Identifier Type: -
Identifier Source: org_study_id
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