Blood Products in Cardiac Surgery

Anemia Clinical Trial

— BiCS  

Official title:

The Use of Blood Products in Patients Undergoing Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02068755
• Other study ID #: BiCS
• Status: Completed
• Phase: N/A
• First received: February 19, 2014
• Last updated: February 19, 2014
• Start date: January 2002
• Est. completion date: December 2012

Study information

• Verified date: February 2014
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: National Supervisory Authority for welfare and Health
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Description:

Registry includes

• >21 000 patients who underwent coronary bypass,

• >4500 patients with aortic valve replacement,

• >4000 mitral valve operation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31000
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cardiac surgery performed in Finnish University and Central hospitals

• Blood product booking for surgery

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia
• Renal Impairment
• Renal Insufficiency
• Thrombocytopenia
• Thrombocytosis

Locations

Country	Name	City	State
n/a

Sponsors (9)

Lead Sponsor	Collaborator
University of Turku	Central Finland Hospital District, Finnish Red Cross, Helsinki University Central Hospital, Kuopio University Hospital, Oulu University Hospital, Satakunta Central Hospital, Tampere University Hospital, Turku University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Red blood cell infusions		12 months	Yes
Primary	Platelet infusion		12 months	Yes
Primary	Fresh frozen plasma		12 months	Yes
Primary	Octaplas		12 months	Yes
Secondary	All cause mortality		12 months	Yes
Secondary	myocardial infarction		12 months	Yes
Secondary	TIA/stroke/arterial embolism		12	Yes
Secondary	re-operation due to bleeding		12 months	Yes