- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03217370
Study on Patient Blood Management in Haematological Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Leuven, Belgium, 3000
- University Hospitals Leuven
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: all haematologists
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
how do haematologists prescribe blood components?
Time Frame: up to 1 year pre measurement and up to 1 year post measurement
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
what's the effect of the interventional phase?
Time Frame: up to 1 year (post measurement)
|
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)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Els Costermans, MD, advanced clinical nurse specialist
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- S60580
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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