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

This study has been terminated.
(After 148 patients enrolled, interim analysis revealed positive results in regard to primary hypothesis.)
Sponsor:
Collaborators:
University Hospital Center Zagreb
Ministry of Science, Education and Sport, Republic of Croatia
Information provided by (Responsible Party):
Petricevic Mate, University of Zagreb
ClinicalTrials.gov Identifier:
NCT01281397
First received: January 19, 2011
Last updated: December 1, 2014
Last verified: December 2014
  Purpose

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
Heart Disease
Coronary Artery Disease
Aortic Valve Disease
Mitral Valve Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bleeding Prediction in Patients Undergoing Cardiac Surgery Using Whole Blood Impedance Aggregometry and Rotational Thromboelastometry

Resource links provided by NLM:


Further study details as provided by University of Zagreb:

Primary Outcome Measures:
  • Chest tube output in first 24 hours [ Time Frame: 24 hours after surgical procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Allogenic blood products transfusion [ Time Frame: 7 days after surgery including the day of surgery ] [ Designated as safety issue: No ]

Enrollment: 148
Study Start Date: August 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients undergoing elective cardiac surgery with cardiopulmonary bypass are enrolled in study.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01281397

Locations
Croatia
University hospital center Zagreb- Rebro
Zagreb, Croatia, 10000
Sponsors and Collaborators
University of Zagreb
University Hospital Center 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
  More Information

No publications provided by University of Zagreb

Additional 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
Study First Received: January 19, 2011
Last Updated: December 1, 2014
Health Authority: Croatia: Ministry of Science, Education and Sports

Keywords provided by University of Zagreb:
cardiac surgery
aggregometry
thromboelastometry
platelet function
bleeding
antiplatelet therapy

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

ClinicalTrials.gov processed this record on March 03, 2015