Common Causes of Blood Transfusion Events in a University Hospital: Analysis of Incident Reports

Blood Transfusion Events Clinical Trial

Official title:

Common Causes of Blood Transfusion Events in a University Hospital: Analysis of Incident Reports.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01812499
• Other study ID #: S55141
• Status: Completed
• Phase: N/A
• First received: February 12, 2013
• Last updated: March 13, 2013
• Start date: January 2013

Study information

• Verified date: February 2013
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all transfusion events reported in the University Hospitals Leuven between January 2011 and July 2012

• Both severe accidents and near misses were included

Exclusion Criteria:

• Transfusion reactions

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Blood Transfusion Events

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of inhospital blood transfusion events	The number of transfusion events divided by the total number of transfused blood products in the study period	up to 1,5 years	No
Other	Is there a relation between misidentification events and the setting where the event took place?	The different settings where the events took place will be compared using a chi-square test (p<0,05).	up to 1,5 years	No
Primary	Severity of inhospital blood transfusion events	included events will be classified into near misses or severe incidents	up to 1,5 years	Yes
Secondary	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.	up to 1,5 years	No