The Effects of Steroids on Coagulation Dysfunction Induced by Cardiopulmonary Bypass: A Steroids in Cardiac Surgery (SIRS) Trial Substudy

D. Paparella, A. Parolari, C. Rotunno, J. Vincent, V. Myasoedova, P. Guida, M. De Palo, V. Margari, P.J. Devereaux, A. Lamy, F. Alamanni, S. Yusuf, R. Whitlock

Research output: Contribution to journalArticle


Cardiopulmonary bypass (CPB) surgery, despite heparin administration, elicits activation of coagulation system resulting in coagulopathy. Anti-inflammatory effects of steroid treatment have been demonstrated, but its effects on coagulation system are unknown. The primary objective of this study is to assess the effects of methylprednisolone on coagulation function by evaluating thrombin generation, fibrinolysis, and platelet activation in high-risk patients undergoing cardiac surgery with CPB. The Steroids In caRdiac Surgery study is a double-blind, randomized, controlled trial performed on 7507 patients worldwide who were randomized to receive either intravenous methylprednisolone, 250 mg at anesthetic induction and 250 mg at initiation of CPB (n = 3755), or placebo (n = 3752). A substudy was conducted in 2 sites to collect blood samples perioperatively to measure prothrombin fragment 1.2 (PF1+2, thrombin generation), plasmin-antiplasmin complex (PAP, fibrinolysis), platelet factor 4 (PF4 platelet activation), and fibrinogen. Eighty-one patients were enrolled in the substudy (37 placebo vs 44 in treatment group). No difference in clinical outcome was detected, including postoperative bleeding and need for blood products transfusion. All patients showed changes of all plasma biomarkers with greater values than baseline in both groups. This reaction was attenuated significantly in the treatment group for PF1.2 (P = 0.040) and PAP (P = 0.042) values at the first intraoperative measurement. No difference between groups was detected for PF4. Methylprednisolone treatment attenuates activation of coagulation system in high-risk patients undergoing CPB surgery. Reduction of thrombin generation and fibrinolysis activation may lead to reduced blood loss after surgery. © 2017 Elsevier Inc.
Original languageEnglish
Pages (from-to)35-44
Number of pages10
JournalSeminars in Thoracic and Cardiovascular Surgery
Issue number1
Publication statusPublished - 2017



  • aortic valve
  • coagulation
  • fibrinolysis
  • inflammation
  • minimally invasive
  • mitral valve
  • antiplasmin
  • fibrinogen
  • fresh frozen plasma
  • methylprednisolone
  • placebo
  • plasmin
  • plasmin antiplasmin complex
  • prothrombin
  • prothrombin fragment 1.2
  • steroid
  • thrombin
  • thrombocyte factor 4
  • unclassified drug
  • biological marker
  • glucocorticoid
  • aged
  • aortic surgery
  • Article
  • blood clotting disorder
  • blood transfusion
  • cardiopulmonary bypass
  • controlled study
  • coronary artery bypass surgery
  • female
  • heart surgery
  • heart valve surgery
  • high risk patient
  • human
  • major clinical study
  • male
  • multicenter study (topic)
  • postoperative hemorrhage
  • randomized controlled trial (topic)
  • adverse effects
  • blood
  • blood clotting
  • blood clotting parameters
  • blood clotting test
  • Blood Loss, Surgical
  • clinical trial
  • double blind procedure
  • drug administration
  • drug effects
  • intravenous drug administration
  • Italy
  • metabolism
  • middle aged
  • multicenter study
  • Ontario
  • randomized controlled trial
  • risk factor
  • thrombocyte activation
  • time factor
  • treatment outcome
  • very elderly
  • Administration, Intravenous
  • Aged
  • Aged, 80 and over
  • Biomarkers
  • Blood Coagulation
  • Blood Coagulation Tests
  • Cardiac Surgical Procedures
  • Cardiopulmonary Bypass
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Fibrinolysis
  • Glucocorticoids
  • Humans
  • Male
  • Methylprednisolone
  • Middle Aged
  • Platelet Activation
  • Platelet Function Tests
  • Postoperative Hemorrhage
  • Risk Factors
  • Thrombin
  • Time Factors
  • Treatment Outcome

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