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NCT01281397 Clinical Trial

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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01281397
Other study ID # Project code: 198-1980976-097
Secondary ID
Status Terminated
Phase N/A
First received January 19, 2011
Last updated December 1, 2014
Start date August 2009
Est. completion date January 2011

Study information
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

Clinical Trial 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.

Recruitment information / eligibility
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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Croatia University hospital center Zagreb- Rebro Zagreb

Sponsors (3)
Lead Sponsor Collaborator
University of Zagreb Clinical Hospital Centre Zagreb, Ministry of Science, Education and Sport, Republic of Croatia

Country where clinical trial is conducted

Croatia, 

Outcome
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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