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Completed

NCT Number: NCT01812499

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.

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Key information

Conditions

Blood Transfusion Events

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Leuven

Leuven, Belgium

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Severity of inhospital blood transfusion events

    Time frame: up to 1,5 years

    included events will be classified into near misses or severe incidents

Secondary outcomes

  1. Causes of inhospital blood transfusion events

    Time frame: up to 1,5 years

    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.

Other outcomes

  1. Incidence of inhospital blood transfusion events

    Time frame: up to 1,5 years

    The number of transfusion events divided by the total number of transfused blood products in the study period

  2. Is there a relation between misidentification events and the setting where the event took place?

    Time frame: up to 1,5 years

    The different settings where the events took place will be compared using a chi-square test (p<0,05).

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
First posted
Mar 18, 2013
Registry last updated
Mar 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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