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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT02277379
Date of registration: 26/10/2014
Prospective Registration: No
Primary sponsor: University of Zagreb
Public title: Prediction of Bleeding and Transfusion Outcomes and Assessment of Perioperative Platelet Reactivity in Cardiac Surgery
Scientific title: Prediction of Bleeding Outcomes / Transfusion Requirements and Assessment of Perioperative Changes in Platelet Reactivity Using Point-of-care Platelet Function Testing in Patients Undergoing Cardiac Surgery
Date of first enrolment: September 2014
Target sample size: 113
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT02277379
Study type:  Observational
Study design:  Observational Model: Cohort, Time Perspective: Prospective  
Phase:  N/A
Countries of recruitment
Croatia
Contacts
Name:     Mate Petricevic, M.D., Ph.D.
Address: 
Telephone:
Email:
Affiliation:  University Hospital Center Zagreb
Key inclusion & exclusion 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 , clopidogrel and prasugrel

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Heart Disease
Intervention(s)
Primary Outcome(s)
postoperative chest tube output [Time Frame: the first 24 postoperative hours]
Secondary Outcome(s)
Transfusion requirements [Time Frame: 5 days]
reexploration for bleeding [Time Frame: 3 days]
Secondary ID(s)
KBCZG8.1-14/62-2
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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