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

NCT01281397 | Terminated DMC

• 1 other identifier: Project code: 198-1980976-097
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Disease; Coronary Artery Disease; Aortic Valve Disease; Mitral Valve Disease

Keywords

cardiac surgery; aggregometry; thromboelastometry; platelet function; bleeding; antiplatelet therapy

Outcome Measures

Primary Outcomes (1)

• Chest tube output in first 24 hours

  24 hours after surgical procedure

Secondary Outcomes (1)

• Allogenic blood products transfusion

  7 days after surgery including the day of surgery

Study Arms (1)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zagreb: lead
• Clinical Hospital Centre Zagreb: collaborator
• Ministry of Science, Education and Sport, Republic of Croatia: collaborator

Study Sites (1)

University hospital center Zagreb- Rebro

Zagreb, Croatia, 10000, Croatia

Location

Related Publications (1)

• Petricevic M, Biocina B, Milicic D, Svetina L, Boban M, Lekic A, Konosic S, Milosevic M, Gasparovic H. Activated coagulation time vs. intrinsically activated modified rotational thromboelastometry in assessment of hemostatic disturbances and blood loss after protamine administration in elective cardiac surgery: analysis from the clinical trial (NCT01281397). J Cardiothorac Surg. 2014 Sep 17;9:129. doi: 10.1186/1749-8090-9-129.

  PMID: 25231271 DERIVED

MeSH Terms

Conditions

Heart Diseases; Coronary Artery Disease; Aortic Valve Disease; Hemorrhage

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Heart Valve Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mate Petricevic, M.D.

  University hospital center Zagreb- Rebro

  PRINCIPAL INVESTIGATOR

• Bojan Biocina, M.D., Ph.D.

  University hospital center Zagreb - Rebro

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mate Petricevic M.D. , Ph.D.

Study Record Dates

• First Submitted: January 19, 2011
• First Posted: January 21, 2011
• Study Start: August 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

CR (1)