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

Sponsor

University of Zagreb (Other)

Overall Status

Terminated

CT.gov ID

NCT01281397

Collaborator

Clinical Hospital Centre Zagreb (Other), Ministry of Science, Education and Sport, Republic of Croatia (Other)

148

Enrollment

Location

Duration (Months)

8.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Disease Coronary Artery Disease Aortic Valve Disease Mitral Valve Disease

Study Design

Study Type:

Observational

Actual Enrollment :

148 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Aug 1, 2009

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Chest tube output in first 24 hours [24 hours after surgical procedure]

Secondary Outcome Measures

Allogenic blood products transfusion [7 days after surgery including the day of surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University hospital center Zagreb- Rebro	Zagreb		Croatia	10000

Sponsors and Collaborators

University of Zagreb
Clinical Hospital Centre Zagreb
Ministry of Science, Education and Sport, Republic of Croatia

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