Prediction of Bleeding and Transfusion Outcomes and Assessment of Perioperative Platelet Reactivity in Cardiac Surgery

NCT02277379 | Completed

• 1 other identifier: KBCZG8.1-14/62-2
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

Excessive bleeding after cardiopulmonary bypass (CPB) operations remains to be a persistent problem. Antiplatelet therapy (APT) is an integral component of perioperative management in patients undergoing cardiac surgery. The impact of drug induced platelet inhibition on early postoperative bleeding extent and transfusion requirements remains difficult to predict. In addition to, resistance to antiplatelet drugs as well as perioperative increase in platelet reactivity following CPB has been reported but this phenomenon has to be comprehensively investigated. The best point-of-care platelet function test to predict bleeding complications/transfusion requirements remains unclear. In addition to, the best test platelet function test to monitor resistance to antiplatelet therapy and its impact on clinical outcomes remains elusive. The aim of this study is:

1. 1.to compare two point-of-care platelet function analyzers (Multiplate and ROTEM Platelet) in regard to prediction of bleeding complications/trasfusion requirements.
2. 2.to compare two point-of-care platelet function analyzers (Multiplate and ROTEM Platelet) in regard to detection of high "on-treatment" platelet reactivity both pre- and postoperatively.

Conditions

Heart Disease

Keywords

cardiac surgery ; hemorrhage ; transfusion requirements

Outcome Measures

Primary Outcomes (1)

• postoperative chest tube output

  Chest tube output (CTO) was determined as study's primary outcome. To estimate blood loss, we will meticulously document CTO, in first 24 postoperative hours and divide it by patient's weight. Drainage loss will be assessed after completion of a 30-minute stabilization period. Blood loss during the stabilization period will not be included in the definition of postoperative hemorrhage. Such loss may be caused by postural changes when transferring the patient from the operating room table to the bed or because of fluid in the pleural or mediastinal cavity, which may have arisen from the rinsing with water as an attempt to achieve surgical hemostasis.

  the first 24 postoperative hours

Secondary Outcomes (2)

• Transfusion requirements

  5 days

• reexploration for bleeding

  3 days

Other Outcomes (1)

• 30 day mortality

  30 day

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

Adult patients undergoing elective cardiac surgery procedures will be consecutively enrolled.

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 , clopidogrel and prasugrel
• 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

Study Sites (1)

UHC Zagreb

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Heart Diseases; Hemorrhage

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mate Petricevic, M.D., Ph.D.

  Clinical Hospital Centre Zagreb

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 26, 2014
• First Posted: October 29, 2014
• Study Start: September 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: January 9, 2015

Record last verified: 2015-01

Locations

CR (1)