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Bleeding Prediction in Patients Following Cardiac Surgery Using Whole Blood Aggregometry and Thromboelastometry

Bleeding Prediction in Patients Undergoing Cardiac Surgery Using Whole Blood Impedance Aggregometry and Rotational Thromboelastometry

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01281397
Enrollment
148
Registered
2011-01-21
Start date
2009-08-31
Completion date
2011-01-31
Last updated
2014-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Disease, Coronary Artery Disease, Heart Disease, Mitral Valve Disease

Keywords

cardiac surgery, aggregometry, thromboelastometry, platelet function, bleeding, antiplatelet therapy

Brief summary

Use of whole blood impedance aggregometry and rotational thromboelastometry can reveal useful data about platelet function and viscoelastic properties of blood clot in patients undergoing cardiac surgery. The purpose of this study is to clarify whether it is possible to predict patients on excessive risk of perioperative bleeding using whole blood impedance aggregometry and rotational thromoelastometry. Antiplatelet therapy is the cornerstone in treatment of patients with coronary artery disease. Another research goal is to determine the degree of response to antiplatelet therapy before and after surgery and to investigate whether patients by level of response to antiplatelet therapy before surgery have a higher risk of perioperative bleeding.

Interventions

None listed

Sponsors

Clinical Hospital Centre Zagreb
CollaboratorOTHER
Ministry of Science, Education and Sport, Republic of Croatia
CollaboratorOTHER_GOV
University of Zagreb
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. \> 18 years old 2. Elective cardiac surgery patients 3. Coronary artery disease 4. Aortic valve disease 5. Mitral valve disease 6. Ascendent aorta aneurysm 7. Combine coronary and valve disease 8. Cardiac surgery procedures using cardiopulmonary bypass

Exclusion criteria

1. Missing consent 2. Patients with emergent cardiac surgical procedures 3. Patients on antiplatelet therapy other than aspirin or clopidogrel 4. Patients with inaccurate antiplatelet therapy administration documentation 5. Missing data 6. Off-pump procedures 7. Patients younger than 18 years old 8. Patients with severe mental disorders 9. Intrinsic coagulopathy

Design outcomes

Primary

MeasureTime frame
Chest tube output in first 24 hours24 hours after surgical procedure

Secondary

MeasureTime frame
Allogenic blood products transfusion7 days after surgery including the day of surgery

Countries

Croatia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026