Bleeding Prediction in Patients Following Cardiac Surgery Using Whole Blood Aggregometry and Thromboelastometry
NCT ID: NCT01281397
Last Updated: 2014-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
148 participants
OBSERVATIONAL
2009-08-31
2011-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients undergoing elective cardiac surgery
Patients undergoing elective cardiac surgery will be enrolled in study. Data about antiplatelet therapy ingestion prior to surgery will be included.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Clinical Hospital Centre Zagreb
OTHER
Ministry of Science, Education and Sport, Republic of Croatia
OTHER_GOV
University of Zagreb
OTHER
Responsible Party
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Petricevic Mate
Mate Petricevic M.D. , Ph.D.
Principal Investigators
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Mate Petricevic, M.D.
Role: PRINCIPAL_INVESTIGATOR
University hospital center Zagreb- Rebro
Bojan Biocina, M.D., Ph.D.
Role: STUDY_CHAIR
University hospital center Zagreb - Rebro
Locations
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University hospital center Zagreb- Rebro
Zagreb, Croatia, Croatia
Countries
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References
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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.
Other Identifiers
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Project code: 198-1980976-097
Identifier Type: -
Identifier Source: org_study_id