Clinical trial NCT01281397: Bleeding Prediction in Patients Following Cardiac Surgery Using Whole Blood Aggregometry and Thromboelastometry
Official title: Bleeding Prediction in Patients Undergoing Cardiac Surgery Using Whole Blood Impedance Aggregometry and Rotational Thromboelastometry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Disease
Coronary Artery Disease
Aortic Valve Disease
Mitral Valve Disease
Keywords: cardiac surgery
aggregometry
thromboelastometry
platelet function
bleeding
antiplatelet therapy
Lead sponsor: University of Zagreb
Sponsor class: OTHER
Collaborators: name: Clinical Hospital Centre Zagreb
name: Ministry of Science, Education and Sport, Republic of Croatia
First posted: 2011-01-21
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing elective cardiac surgery with cardiopulmonary bypass are enrolled in study.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Chest tube output in first 24 hours
timeFrame: 24 hours after surgical procedure
Secondary outcomes:
measure: Allogenic blood products transfusion
timeFrame: 7 days after surgery including the day of surgery
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University hospital center Zagreb- Rebro
Study officials:
affiliation: University hospital center Zagreb- Rebro
name: Mate Petricevic, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University hospital center Zagreb - Rebro
name: Bojan Biocina, M.D., Ph.D.
role: STUDY_CHAIR
References:
citation: Petricevic M, Biocina B, Milicic D, Svetina L, Boban M, Lekic A, Konosic S, Milosevic M, Gasparovic H. Activated coagulation time vs. intrinsically activated modified rotational thromboelastometry in assessment of hemostatic disturbances and blood loss after protamine administration in elective cardiac surgery: analysis from the clinical trial (NCT01281397). J Cardiothorac Surg. 2014 Sep 17;9:129. doi: 10.1186/1749-8090-9-129.