- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01281397
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
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Zagreb, Croatia, 10000
- University hospital center Zagreb- Rebro
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- > 18 years old
- Elective cardiac surgery patients
- Coronary artery disease
- Aortic valve disease
- Mitral valve disease
- Ascendent aorta aneurysm
- Combine coronary and valve disease
- Cardiac surgery procedures using cardiopulmonary bypass
Exclusion Criteria:
- Missing consent
- Patients with emergent cardiac surgical procedures
- Patients on antiplatelet therapy other than aspirin or clopidogrel
- Patients with inaccurate antiplatelet therapy administration documentation
- Missing data
- Off-pump procedures
- Patients younger than 18 years old
- Patients with severe mental disorders
- Intrinsic coagulopathy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Chest tube output in first 24 hours
Time Frame: 24 hours after surgical procedure
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24 hours after surgical procedure
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Allogenic blood products transfusion
Time Frame: 7 days after surgery including the day of surgery
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7 days after surgery including the day of surgery
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mate Petricevic, M.D., University hospital center Zagreb- Rebro
- Study Chair: Bojan Biocina, M.D., Ph.D., University hospital center Zagreb - Rebro
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Project code: 198-1980976-097
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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