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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01281397
Recruitment Status : Terminated (After 148 patients enrolled, interim analysis revealed positive results in regard to primary hypothesis.)
First Posted : January 21, 2011
Last Update Posted : December 3, 2014
Information provided by (Responsible Party):

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
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 : August 2009
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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 :
  1. Chest tube output in first 24 hours [ Time Frame: 24 hours after surgical procedure ]

Secondary Outcome Measures :
  1. Allogenic blood products transfusion [ Time Frame: 7 days after surgery including the day of surgery ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing elective cardiac surgery with cardiopulmonary bypass are enrolled in study.

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01281397

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
Principal Investigator: Mate Petricevic, M.D. University hospital center Zagreb- Rebro
Study Chair: Bojan Biocina, M.D., Ph.D. University hospital center Zagreb - Rebro
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Petricevic Mate, Mate Petricevic M.D. , Ph.D., University of Zagreb
ClinicalTrials.gov Identifier: NCT01281397     History of Changes
Other Study ID Numbers: Project code: 198-1980976-097
First Posted: January 21, 2011    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by Petricevic Mate, University of Zagreb:
cardiac surgery
platelet function
antiplatelet therapy

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes