Study on Patient Blood Management in Haematological Patients

Blood Transfusion Clinical Trial

Official title:

Study on Patient Blood Management in Haematological Patients

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03217370
• Other study ID #: S60580
• Status: Suspended
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: September 30, 2021

Study information

• Verified date: February 2019
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study is set up as a first step of implementing patient blood management (PBM) in this hospital. PBM is an evidence-based, multidisciplinary approach to optimizing the care of patients who might need transfusion. Not only in pre/per/postoperative setting but also in haematology PBM guidelines can be implemented. Examples are: use of a restrictive haemoglobin trigger for red blood cells (RBC) transfusion, single use policy for the administration of RBC and platelets, administration only for correct indications (including the introduction of an electronic clinical decision support system for ordering blood components), ...

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 700
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• ambulatory patients

• patients without blood transfusion administered in their hospitalised period

• patients with no haematological illness that were hospitalised at the haematological wards

Related Conditions & MeSH terms

• Blood Transfusion
• Haematology

Intervention

Other:
• education of guidelines
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

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
Primary	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	what's the effect of the interventional phase?	The investigators will again 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 after the intervention phase. For which indication is blood ordered? Is the Haemoglobin level known before the order is send to the blood bank? Did the interventions lead to less prescriptions/administrations of blood components and more single unit transfusion? We will use SPSS for statistical analysis (frequencies, percentages and means, scatter plots)	up to 1 year (post measurement)