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

December 1, 2014 updated by: Petricevic Mate, University of Zagreb

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

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

148

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • University hospital center Zagreb- Rebro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Chest tube output in first 24 hours
Time Frame: 24 hours after surgical procedure
24 hours after surgical procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Allogenic blood products transfusion
Time Frame: 7 days after surgery including the day of surgery
7 days after surgery including the day of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zagreb

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

January 19, 2011

First Submitted That Met QC Criteria

January 20, 2011

First Posted (Estimate)

January 21, 2011

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Project code: 198-1980976-097

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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