Coronary Artery Disease Clinical Trial
Official title:
Bleeding Prediction in Patients Undergoing Cardiac Surgery Using Whole Blood Impedance Aggregometry and Rotational Thromboelastometry
Verified date | December 2014 |
Source | University of Zagreb |
Contact | n/a |
Is FDA regulated | No |
Health authority | Croatia: Ministry of Science, Education and Sports |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 148 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Croatia | University hospital center Zagreb- Rebro | Zagreb |
Lead Sponsor | Collaborator |
---|---|
University of Zagreb | Clinical Hospital Centre Zagreb, Ministry of Science, Education and Sport, Republic of Croatia |
Croatia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Chest tube output in first 24 hours | 24 hours after surgical procedure | No | |
Secondary | Allogenic blood products transfusion | 7 days after surgery including the day of surgery | No |
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