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

Terminated

• Conditions: Heart Disease; Aortic Valve Disease; Coronary Artery Disease; Mitral Valve Disease

• Registration Number: NCT01281397
• Lead Sponsor: University of Zagreb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Study First Submitted: 2011-01-19
• Study First Submitted QC: 2011-01-20
• Study First Posted: 2011-01-21
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 148

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chest tube output in first 24 hours	24 hours after surgical procedure

Secondary Outcome Measures

Name	Time	Method
Allogenic blood products transfusion	7 days after surgery including the day of surgery

Trial Locations

Locations (1)

University hospital center Zagreb- Rebro; 🇭🇷 Zagreb, Croatia