The goal of this observational study is to learn how flow-based platelet function measured with the Total Thrombus-formation Analysis System (T-TAS) relates to early postoperative bleeding in adults undergoing cardiac surgery with cardiopulmonary bypass. The study will also evaluate how T-TAS changes during the perioperative period and how it compares with standard coagulation and platelet function tests.
The main questions it aims to answer are:
Is lower post-cardiopulmonary bypass T-TAS Platelet-chip (PL-chip) thrombus formation associated with increased postoperative chest tube drainage during the first 12 hours after surgery? How do T-TAS parameters change before surgery, immediately after cardiopulmonary bypass, and 24 hours after surgery? Are abnormal T-TAS results associated with blood transfusion requirements, major bleeding, re-exploration for bleeding, and length of stay in the intensive care unit and hospital? Does T-TAS provide complementary information compared with standard coagulation tests, von Willebrand factor (vWF) measurements, platelet aggregometry, and viscoelastic testing?
Participants will:
Undergo blood sampling at three predefined perioperative time points:
before anesthesia induction, immediately after cardiopulmonary bypass and heparin reversal with protamine, and 24 hours after surgery Have T-TAS testing, standard laboratory coagulation tests, vWF testing, platelet aggregometry, and viscoelastic testing performed on collected samples Have clinical, surgical, transfusion, and postoperative bleeding data collected during their hospital stay
The study is observational and does not require changes to routine clinical care or perioperative management.
Adults aged 18 years or older
Undergoing elective or urgent cardiac surgery requiring cardiopulmonary bypass
Ability to provide written informed consent
Cardiac surgery performed without cardiopulmonary bypass
Emergency cardiac surgery
Preoperative anticoagulation not reversed at the time of surgery
Refusal or withdrawal of informed consent
Adult patients undergoing elective or urgent cardiac surgery requiring cardiopulmonary bypass at a tertiary academic cardiac surgery center. Participants are recruited prospectively during routine perioperative clinical care and undergo perioperative assessment of flow-based platelet function using the Total Thrombus-formation Analysis System (T-TAS).
Cohort
Prospective
Total Thrombus-formation Analysis System (T-TAS)
Diagnostic testPerioperative assessment of flow-based thrombus formation in whole blood using the Total Thrombus-formation Analysis System (T-TAS), including PL-chip analysis and exploratory AR-chip analysis at predefined perioperative time points during adult cardiac surgery with cardiopulmonary bypass.
12-Hour Postoperative Chest Tube Drainage
Cumulative postoperative chest tube drainage volume (mL) measured from ICU admission through the first 12 hours after cardiac surgery with cardiopulmonary bypass.
24-Hour Postoperative Chest Tube Drainage
Cumulative postoperative chest tube drainage volume (mL) measured from ICU admission through the first 24 hours after cardiac surgery with cardiopulmonary bypass.
Perioperative Blood Transfusion Exposure
Receipt of allogeneic blood products, including packed red blood cells, fresh frozen plasma, platelets, and fibrinogen-containing products, from the start of surgery through hospital discharge.
Surgical Re-exploration for Bleeding
Occurrence of surgical re-exploration for postoperative bleeding or cardiac tamponade requiring return to the operating room after cardiac surgery with cardiopulmonary bypass.
Intensive Care Unit Length of Stay
Duration of postoperative intensive care unit stay measured in days.
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