Clinical trial NCT02068755: Blood Products in Cardiac Surgery
Official title: The Use of Blood Products in Patients Undergoing Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Renal Impairment
Thrombocytopenia
Keywords: anemia
renal impairment
thrombocytopenia
anticoagulation
Coronary bypass
Aortic valve surgery
Mitral valve surgery
red blood cell
platelet
fresh frozen plasma
octaplas
Lead sponsor: University of Turku
Sponsor class: OTHER
Collaborators: name: Finnish Red Cross Blood Service
name: Central Finland Hospital District
name: Turku University Hospital
name: Oulu University Hospital
name: Tampere University Hospital
name: Kuopio University Hospital
name: Helsinki University Central Hospital
name: Satakunta Central Hospital
First posted: 2014-02-21
Enrollment: 31000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Red blood cell infusions
timeFrame: 12 months
measure: Platelet infusion
timeFrame: 12 months
measure: Fresh frozen plasma
timeFrame: 12 months
measure: Octaplas
timeFrame: 12 months
Secondary outcomes:
measure: All cause mortality
timeFrame: 12 months
measure: myocardial infarction
timeFrame: 12 months
measure: TIA/stroke/arterial embolism
timeFrame: 12
measure: re-operation due to bleeding
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Central Finland Central Hospital
name: Pirjo Mustonen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Turku University Hospital and University of Turku
name: Juhani Airaksinen, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Oulu University Hospital
name: Fausto Biancari, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Turku University Hospital and University of Turku
name: Tuomas O Kiviniemi, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References: