Blood Transfusion EventsNCT01812499
Common Causes of Blood Transfusion Events in a University Hospital: Analysis of Incident Reports
An observational study of Blood Transfusion Events, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Inhospital the blood transfusion process consists of many phases: ordering the blood product, analysis of the blood sample, delivery, transport and storage of the blood product and administration. In each of these phases (near) accidents may occur. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Blood Transfusion Events
- How many people
- 131 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2013to Feb 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients in a university hospital which experienced a transfusion event
Who may be able to join
- all transfusion events reported in the University Hospitals Leuven between January 2011 and July 2012
- Both severe accidents and near misses were included
Who cannot join
- Transfusion reactions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Common Causes of Blood Transfusion Events in a University Hospital: Analysis of Incident Reports.
Inhospital the blood transfusion process consists of many phases: ordering the blood product, analysis of the blood sample, delivery, transport and storage of the blood product and administration. In each of these phases (near) accidents may occur. A severe transfusion incident refers to the transfusion of a wrong blood product, whereas a near miss is detected before transfusion.
In 2010 the University Hospitals Leuven introduced a new electronic patient incident report system for transfusion events.
In this study the investigators will analyze the reported blood transfusion events to detect the most common causes of blood transfusion events and the weakest link in the blood transfusion chain.
Read the detailed description
A retrospective survey will be conducted of all transfusion events reported in the University Hospitals Leuven between January 2011 and July 2012. Both severe accidents and near misses will be included.
Data will be drawn from the incident report system. Data concerning the number of transfused blood products will be required from the Medical Administration Service.
Events will be classified according to the severity and the cause of the event. The different settings where the events took place will be compared using a chi-square test (p<0,05).
- Conditions
- Blood Transfusion Events
- Keywords
- blood transfusion, adverse event, incident reporting
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of inhospital blood transfusion events
included events will be classified into near misses or severe incidents
Measured: up to 1,5 years
Secondary outcomes (1)
Causes of inhospital blood transfusion events
Events are classified into human error, technical problems, deficiency of the blood product and others.
Events will also be classified considering the phase in the blood transfusion process.
Causes will be studied hospital wide and per setting were the event took place.
Measured: up to 1,5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Transfusion EventsStudies 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
- Time perspective
- Retrospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy Devos, MD, PhD, Study director, Department of Hematology, University Hospitals Leuven, Herestraat 49, 3000 Leuven, BelgiumEls Costermans, RN, Principal investigator, Department of Hematology, University Hospitals Leuven, Herestraat 49, 3000 Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812499
- Sponsor's protocol ID
- S55141
- Status last verified
- Feb 2013
- First submitted
- 12 Feb 2013
- Last updated
- 18 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Common Causes of Blood Transfusion Events in a University Hospital: Analysis of Incident Reports.
- ClinicalTrials.gov ID
- NCT01812499
- Acronym / sponsor ID
- S55141
- Conditions
- Blood Transfusion Events
- Keywords
- blood transfusion, adverse event, incident reporting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Feb 2013 (actual)
- First posted
- 18 Mar 2013 (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.
Inhospital the blood transfusion process consists of many phases: ordering the blood product, analysis of the blood sample, delivery, transport and storage of the blood product and administration. In each of these phases (near) accidents may occur. A severe transfusion incident refers to the transfusion of a wrong blood product, whereas a near miss is detected before transfusion.
In 2010 the University Hospitals Leuven introduced a new electronic patient incident report system for transfusion events.
In this study the investigators will analyze the reported blood transfusion events to detect the most common causes of blood transfusion events and the weakest link in the blood transfusion chain.
Detailed description
A retrospective survey will be conducted of all transfusion events reported in the University Hospitals Leuven between January 2011 and July 2012. Both severe accidents and near misses will be included.
Data will be drawn from the incident report system. Data concerning the number of transfused blood products will be required from the Medical Administration Service.
Events will be classified according to the severity and the cause of the event. The different settings where the events took place will be compared using a chi-square test (p<0,05).
Study design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients in a university hospital which experienced a transfusion event
Key inclusion criteria (2 listed)
- all transfusion events reported in the University Hospitals Leuven between January 2011 and July 2012
- Both severe accidents and near misses were included
Key exclusion criteria (1 listed)
- Transfusion reactions
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
Severity of inhospital blood transfusion events
Time frame: up to 1,5 years
included events will be classified into near misses or severe incidents
1 secondary outcome
Causes of inhospital blood transfusion events
Time frame: up to 1,5 years
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 18 Mar 2013.
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, MD, PhD study director
Department of Hematology, University Hospitals Leuven, Herestraat 49, 3000 Leuven, Belgium
Els Costermans, RN principal investigator
Department of Hematology, University Hospitals Leuven, Herestraat 49, 3000 Leuven, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Transfusion Events, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 18 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Severity of inhospital blood transfusion events (time frame: up to 1,5 years). 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 18 Mar 2013; AzTrials last refreshed its copy on 8 Nov 2026.