Blood SafetyNCT02513966
Decreased Consumption of Blood Components During Cardiac Surgery Procedures: Causes and Effects.
An observational study of Blood Safety and Blood Transfusion, run by Universitaire Ziekenhuizen KU Leuven.
Trial summary
There is a decrease in the amount of blood components used during cardiac surgery in the last four years. As the hemovigilance team of the investigators' Hospital the investigators want to find out the causes and effects of this decrease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Safety, Blood Transfusion
- How many people
- 7,835 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to 18 May 2022
- 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: All patients undergoing cardiac surgery from 2010 untill 2014 in the University Hospitals of Leuven.
Who may be able to join
- patient underwent cardiac surgery between 2010 and 2014 in UZ Leuven
Who cannot join
- patient without cardiac surgery
About this study
There is a decrease in the amount of blood components used during cardiac surgery in the last four years. As the hemovigilance team of the investigators' Hospital the investigators want to find out the causes and effects of this decrease.
- Conditions
- Blood Safety, Blood Transfusion
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of blood use during Cardiac surgery
Measured: 5years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study startJul 2015
- Primary completion17 May 2022
- Study completion18 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood SafetyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 7,835 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy Devos, master, Study chair, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513966
- Sponsor's protocol ID
- s58228
- Status last verified
- Apr 2021
- First submitted
- 13 Jul 2015
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreased Consumption of Blood Components During Cardiac Surgery Procedures: Causes and Effects.
- ClinicalTrials.gov ID
- NCT02513966
- Acronym / sponsor ID
- s58228
- Conditions
- Blood Safety, Blood Transfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,835 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 18 May 2022 (actual)
- First posted
- 3 Aug 2015 (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.
There is a decrease in the amount of blood components used during cardiac surgery in the last four years. As the hemovigilance team of the investigators' Hospital the investigators want to find out the causes and effects of this decrease.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing cardiac surgery from 2010 untill 2014 in the University Hospitals of Leuven.
Key inclusion criteria (1 listed)
- patient underwent cardiac surgery between 2010 and 2014 in UZ Leuven
Key exclusion criteria (1 listed)
- patient without cardiac surgery
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
amount of blood use during Cardiac surgery
Time frame: 5years
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 27 Jun 2024.
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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.
Timothy Devos, master study chair
Universitaire Ziekenhuizen KU Leuven
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Safety and Blood Transfusion, run by Universitaire Ziekenhuizen KU Leuven.
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 1 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 27 Jun 2024. 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?
amount of blood use during Cardiac surgery (time frame: 5years). 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 27 Jun 2024.