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NCT07619261

Flow-Based Platelet Function (T-TAS) and Early Bleeding After Cardiac Surgery

Sponsor: Hospital de la Santa creu i Sant Pau - Barcelona

View on ClinicalTrials.gov

Summary

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 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 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, von Willebrand factor 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.

Official title: Prospective Observational Study of Flow-Based Platelet Function Using T-TAS and Early Bleeding After Cardiopulmonary Bypass in Adult Cardiac Surgery

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2026-09-15

Completion Date

2027-02-15

Last Updated

2026-06-01

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Total Thrombus-formation Analysis System (T-TAS)

Perioperative 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.