NCT01812499

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 18, 2013

Completed
Last Updated

March 18, 2013

Status Verified

February 1, 2013

Enrollment Period

1 month

First QC Date

February 12, 2013

Last Update Submit

March 13, 2013

Conditions

Blood Transfusion Events

Keywords

blood transfusionadverse eventincident reporting

Outcome Measures

Primary Outcomes (1)

  • Severity of inhospital blood transfusion events

    included events will be classified into near misses or severe incidents

    up to 1,5 years

Secondary Outcomes (1)

  • Causes of inhospital blood transfusion events

    up to 1,5 years

Other Outcomes (2)

  • Incidence of inhospital blood transfusion events

    up to 1,5 years

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

    up to 1,5 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients in a university hospital which experienced a transfusion event

You may qualify if:

  • all transfusion events reported in the University Hospitals Leuven between January 2011 and July 2012
  • Both severe accidents and near misses were included

You may not qualify if:

  • Transfusion reactions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, Belgium

Location

Study Officials

  • Timothy Devos, MD, PhD

    Department of Hematology, University Hospitals Leuven, Herestraat 49, 3000 Leuven, Belgium

    STUDY DIRECTOR

  • Els Costermans, RN

    Department of Hematology, University Hospitals Leuven, Herestraat 49, 3000 Leuven, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2013

First Posted

March 18, 2013

Study Start

January 1, 2013

Primary Completion

February 1, 2013

Last Updated

March 18, 2013

Record last verified: 2013-02

Locations

BE(1)