NCT03217370

Brief Summary

The investigators noticed a variable prescription of blood components to haematological patients in the hospital. This study will analyze the prescription and administration of blood components to Haematological patients (pre measurement). Based on these results guidelines on transfusion triggers will be updated and educated to the physicians and new ICT (information and communications technology) implementations will be added to the electronic order for blood components. The investigators hope to see afterwards (post measurement) a more stable prescription and administration of blood components and a more economic use of blood components.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

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

First Submitted

Initial submission to the registry

July 5, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed
18 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

February 18, 2019

Status Verified

February 1, 2019

Enrollment Period

4.2 years

First QC Date

July 5, 2017

Last Update Submit

February 14, 2019

Conditions

Keywords

patient blood managementrestrictive transfusion

Outcome Measures

Primary Outcomes (1)

  • how do haematologists prescribe blood components?

    The investigators use a questionaire (15-20 questions) to evaluate how haematologists prescribe red blood cells and platelets. Do they analyze the haemoglobin and platelet count before and after each blood transfusion? Do they apply single unit policy for RBC and platelet transfusions? Which triggers are used for RBC and platelet transfusion? Which guidelines are followed? The investigators will send this questionnaire to all haematologists (including haematologists in training) in 2017 (premeasurement) and in 2019-2020 (postmeasurement). The investigators will also use data (which is already available in the patient files) about blood transfusion to evaluate the ordering and administration of blood components during 1 year. For which indication is blood ordered? Is the Haemoglobin level known before the order is send to the blood bank?

    up to 1 year pre measurement and up to 1 year post measurement

Secondary Outcomes (1)

  • what's the effect of the interventional phase?

    up to 1 year (post measurement)

Study Arms (1)

all haematologists

OTHER

There will be only one arm: the haematologists will all be included in the interventional phase. Interventions are: 1) rewriting guidelines to order blood components; 2) to show the last hemoglobin value on the orders for erytrocytes and the last platelet count on the orders dor thrombocytes and 3)implementation of a clinical decision support system in the electronic rodering of blood components to stimulate restrictive blood transfusion.

Other: education of guidelines

Interventions

* Guidelines will be updated and education will be given to haematologists in several ways. * ICT implementations: a) last result of haemoglobin and platelet count will be shown on the electronic blood order; b) an electronical clinical decision support system will be implemented to order blood components

Also known as: ICT implementations in the electronic patient file
all haematologists

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all adult patients hospitalised at the haematology wards of the University Hospitals of Leuven (UZ Leuven) between 01/08/2017 and 31/07/2018 (pre measurement) and between between 01/08/2019 and 31/07/2020 (post measurement)

You may not qualify if:

  • ambulatory patients
  • patients without blood transfusion administered in their hospitalised period
  • patients with no haematological illness that were hospitalised at the haematological wards

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Study Officials

  • Els Costermans, MD

    advanced clinical nurse specialist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: observational cross-sectional study with pre and post measurement and in between an interventional phase with education, IT implementations etc.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2017

First Posted

July 14, 2017

Study Start

August 1, 2017

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

February 18, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations