NCT02068755

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2014

Completed
Last Updated

February 21, 2014

Status Verified

February 1, 2014

Enrollment Period

10.9 years

First QC Date

February 19, 2014

Last Update Submit

February 19, 2014

Conditions

AnemiaRenal ImpairmentThrombocytopenia

Keywords

anemiarenal impairmentthrombocytopeniaanticoagulationCoronary bypassAortic valve surgeryMitral valve surgeryred blood cellplateletfresh frozen plasmaoctaplas

Outcome Measures

Primary Outcomes (4)

  • Red blood cell infusions

    12 months

  • Platelet infusion

    12 months

  • Fresh frozen plasma

    12 months

  • Octaplas

    12 months

Secondary Outcomes (4)

  • All cause mortality

    12 months

  • myocardial infarction

    12 months

  • TIA/stroke/arterial embolism

    12

  • re-operation due to bleeding

    12 months

Study Arms (1)

Cardiac surgery

Patients who have undergone cardiac surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AnemiaRenal InsufficiencyThrombocytopenia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBlood Platelet DisordersCytopenia

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 19, 2014

First Posted

February 21, 2014

Study Start

January 1, 2002

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

February 21, 2014

Record last verified: 2014-02