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

NCT07619261 | Not Yet Recruiting

• 1 other identifier: IRSP-TAS-2026-77
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Cardiac Surgery; Total Thrombus formation Analysis System (T-TAS); Platelet Function; Postoperative Bleeding; Hemostasis; Blood Transfusion; ROTEM; Thrombus Formation; Cardiopulmonary Bypass (CPB); von Willebrand Factor (vWF)

Outcome Measures

Primary Outcomes (1)

• 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.

  From ICU admission through 12 hours after surgery

Secondary Outcomes (5)

• 24-Hour Postoperative Chest Tube Drainage

  From ICU admission through 24 hours after surgery.

• Perioperative Blood Transfusion Exposure

  From surgery through hospital discharge (up to 30 days).

• Surgical Re-exploration for Bleeding

  From surgery through hospital discharge (up to 30 days).

• Intensive Care Unit Length of Stay

  From ICU admission until ICU discharge (up to 30 days).

• Hospital Length of Stay

  From surgery until hospital discharge (up to 90 days).

Study Arms (1)

Adult Cardiac Surgery With Cardiopulmonary Bypass

Adult patients undergoing elective or urgent cardiac surgery requiring cardiopulmonary bypass who undergo perioperative assessment of flow-based platelet function using the Total Thrombus-formation Analysis System (T-TAS). Participants are evaluated at predefined perioperative time points before surgery, immediately after cardiopulmonary bypass, and 24 hours postoperatively as part of a prospective observational cohort study.

Diagnostic Test: Total Thrombus-formation Analysis System (T-TAS)

Interventions

Total Thrombus-formation Analysis System (T-TAS) DIAGNOSTIC_TEST

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.

Adult Cardiac Surgery With Cardiopulmonary Bypass

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• Adults aged 18 years or older
• Undergoing elective or urgent cardiac surgery requiring cardiopulmonary bypass
• Ability to provide written informed consent

You may not qualify if:

• Cardiac surgery performed without cardiopulmonary bypass
• Emergency cardiac surgery
• Preoperative anticoagulation not reversed at the time of surgery
• Refusal or withdrawal of informed consent
• Known pregnancy

Sponsors & Collaborators

• Hospital de la Santa creu i Sant Pau - Barcelona: lead

MeSH Terms

Conditions

Postoperative Hemorrhage

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Study Officials

• Tobias Koller, MD, PhD

  Instituto de Recerca, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Maria Gomez Caro, MD

CONTACT

+34663266681; agomezc@santpau.cat

Tobias Koller, MD, PhD

CONTACT

+34637981674; tkoller@santpau.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiac Surgery ICU, MD, PhD

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 1, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 15, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share