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Flow-Based Platelet Function Assessment Using Total Thrombus-Formation Analysis System (T-TAS) and Early Bleeding After Cardiac Surgery With Cardiopulmonary Bypass (CPB)

NCT07619261 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-06-10

No results posted yet for this study

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 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.

Conditions

  • Perioperative Bleeding
  • Coagulopathy During Cardiac Surgery
  • Platelet Dysfunction
  • Cardiac Surgery
  • Acquired Von Willebrand Disease

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.

Sponsors & Collaborators

  • Hospital de la Santa creu i Sant Pau - Barcelona

    lead OTHER

Principal Investigators

  • Tobias Koller, MD, PhD · Instituto de Recerca, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-15
Primary Completion
2027-02-01
Completion
2027-02-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07619261 on ClinicalTrials.gov