Blood Products in Cardiac Surgery (BiCS)

The Use of Blood Products in Patients Undergoing Cardiac Surgery

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).

Study Overview

• Status: Completed
• Conditions: Anemia; Renal Impairment; Thrombocytopenia

Detailed Description

Registry includes

• >21 000 patients who underwent coronary bypass,
• >4500 patients with aortic valve replacement,
• >4000 mitral valve operation.

• Study Type: Observational
• Enrollment (Actual): 31000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

We collected data from patients who visited underwent cardiac surgery in Finnish hospitals during the years 2002 and 2012. Participating perform all the cardiac surgery in Finland and hospitals were scattered to all geographical areas in Finland.

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cardiac surgery; Patients who have undergone cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Red blood cell infusions	12 months
Platelet infusion	12 months
Fresh frozen plasma	12 months
Octaplas	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
All cause mortality	12 months
myocardial infarction	12 months
TIA/stroke/arterial embolism	12
re-operation due to bleeding	12 months

Collaborators and Investigators

• Sponsor: University of Turku
• Collaborators: Turku University Hospital; Helsinki University Central Hospital; Oulu University Hospital; Kuopio University Hospital; Tampere University Hospital; Central Finland Hospital District; Satakunta Central Hospital; Finnish Red Cross Blood Service
• Investigators: Principal Investigator: Pirjo Mustonen, MD, PhD, Central Finland Central Hospital; Principal Investigator: Juhani Airaksinen, Prof, Turku University Hospital and University of Turku; Principal Investigator: Fausto Biancari, MD, PhD, Oulu University Hospital; Principal Investigator: Tuomas O Kiviniemi, Md, PhD, Turku University Hospital and University of Turku

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: February 19, 2014
• First Submitted That Met QC Criteria: February 19, 2014
• First Posted (Estimate): February 21, 2014

Study Record Updates

• Last Update Posted (Estimate): February 21, 2014
• Last Update Submitted That Met QC Criteria: February 19, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: anemia; platelet; renal impairment; anticoagulation; thrombocytopenia; Mitral valve surgery; red blood cell; fresh frozen plasma; Aortic valve surgery; Coronary bypass; octaplas
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Hematologic Diseases; Blood Platelet Disorders; Renal Insufficiency; Thrombocytopenia
• Other Study ID Numbers: BiCS