AnemiaBiCSNCT02068755
Blood Products in Cardiac Surgery
An observational study of Anemia and Renal Impairment, run by University of Turku.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Renal Impairment, Thrombocytopenia
- How many people
- 31,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2002to Dec 2012
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Cardiac surgery performed in Finnish University and Central hospitals
- Blood product booking for surgery
Who cannot join
- -
About this study
Official title: 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.
Read more
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).
Read the detailed description
Registry includes
- >21 000 patients who underwent coronary bypass,
- >4500 patients with aortic valve replacement,
- >4000 mitral valve operation.
- 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
- Medical subject headings
- Anemia, Renal Insufficiency, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac surgery | Patients who have undergone cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Red blood cell infusions
Measured: 12 months
Platelet infusion
Measured: 12 months
Fresh frozen plasma
Measured: 12 months
Octaplas
Measured: 12 months
Secondary outcomes (4)
All cause mortality
Measured: 12 months
myocardial infarction
Measured: 12 months
TIA/stroke/arterial embolism
Measured: 12
re-operation due to bleeding
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startJan 2002
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31,000 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- Finnish Red Cross Blood Service, Central Finland Hospital District, Turku University Hospital, Oulu University Hospital, Tampere University Hospital, Kuopio University Hospital, Helsinki University Central Hospital, Satakunta Central Hospital
- Responsible party
- Principal investigator, Dr. Pirjo Mustonen, MD, PhD, University of Turku
- Investigators
- Pirjo Mustonen, MD, PhD, Principal investigator, Central Finland Hospital DistrictJuhani Airaksinen, Prof, Principal investigator, Turku University Hospital and University of TurkuFausto Biancari, MD, PhD, Principal investigator, Oulu University HospitalTuomas O Kiviniemi, Md, PhD, Principal investigator, Turku University Hospital and University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068755
- Sponsor's protocol ID
- BiCS
- Acronym
- BiCS
- Status last verified
- Feb 2014
- First submitted
- 19 Feb 2014
- Last updated
- 21 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Blood Products in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02068755
- Acronym / sponsor ID
- BiCS / BiCS
- Conditions
- Anemia, Renal Impairment, Thrombocytopenia
- Keywords
- anemia, renal impairment, thrombocytopenia, anticoagulation, Coronary bypass, Aortic valve surgery, Mitral valve surgery, red blood cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31,000 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- Finnish Red Cross Blood Service, Central Finland Hospital District, Turku University Hospital, Oulu University Hospital, Tampere University Hospital, Kuopio University Hospital, Helsinki University Central Hospital, Satakunta Central Hospital
- Study start
- Jan 2002
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgery | – | –Patients who have undergone cardiac surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Cardiac surgery performed in Finnish University and Central hospitals
- Blood product booking for surgery
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Red blood cell infusions
Time frame: 12 months
Platelet infusion
Time frame: 12 months
Fresh frozen plasma
Time frame: 12 months
Octaplas
Time frame: 12 months
4 secondary outcomes
All cause mortality
Time frame: 12 months
myocardial infarction
Time frame: 12 months
TIA/stroke/arterial embolism
Time frame: 12
re-operation due to bleeding
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2014.
Related trials for Anemia
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pirjo Mustonen, MD, PhD principal investigator
Central Finland Hospital District
Juhani Airaksinen, Prof principal investigator
Turku University Hospital and University of Turku
Fausto Biancari, MD, PhD principal investigator
Oulu University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Renal Impairment, run by University of Turku.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Red blood cell infusions (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2014.