Blood Products in Cardiac Surgery

Completed

• Conditions: Anemia; Renal Impairment; Thrombocytopenia

• Registration Number: NCT02068755
• Lead Sponsor: University of Turku

Brief Summary

Blood transfusion is a common procedure essential for the treatment of patients undergoing cardiac surgery. Inappropriate transfusions, however, not only incur needless healthcare costs, but increase unnecessary risks due to transfusion reactions and infectious and immunomodulative causes. Safe and appropriate patient care requires evaluated blood component prescription practices.

Practically all patients undergoing cardiac surgery in Finland have a blood product booking from the Finnish Red Cross Blood Service. This registry contains large volumes of transfusion-related information on all Finnish patients undergoing cardiac surgery in Finnish centers. Participating hospitals were scattered to all geographical areas in Finland and concentrated to the most populated regions.

Data on the blood product use, laboratory findings one month pre-operatively and 12 months post-operatively were available.

Finnish hospitals have been required to provide information on hospital visits for the Finnish National Research and Development Centre for Welfare and Health for healthcare planning purposes. We used in part the original data sent by hospitals to the Finnish Hospital Discharge Register (FHDR).

Detailed Description

Registry includes

* \>21 000 patients who underwent coronary bypass,

* \>4500 patients with aortic valve replacement,

* \>4000 mitral valve operation.

Study Timeline

• Study Start: 2002-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-02
• Study First Submitted: 2014-02-19
• Study First Submitted QC: 2014-02-19
• Last Update Submitted: 2014-02-19
• Study First Posted: 2014-02-21
• Last Update Posted: 2014-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31000

Inclusion Criteria

• Cardiac surgery performed in Finnish University and Central hospitals
• Blood product booking for surgery

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Red blood cell infusions	12 months
Platelet infusion	12 months
Fresh frozen plasma	12 months
Octaplas	12 months

Secondary Outcome Measures

Name	Time	Method
All cause mortality	12 months
myocardial infarction	12 months
TIA/stroke/arterial embolism	12
re-operation due to bleeding	12 months