Blood TransfusionNCT03217370
Study on Patient Blood Management in Haematological Patients
A study testing education of guidelines in people with Blood Transfusion and Haematology, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Blood Transfusion, Haematology
- What is being tested?
- education of guidelines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2017to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- ambulatory patients
- patients without blood transfusion administered in their hospitalised period
- patients with no haematological illness that were hospitalised at the haematological wards
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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), ...
- Conditions
- Blood Transfusion, Haematology
- Being tested
- education of guidelines
- Keywords
- patient blood management, restrictive transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education of guidelinesOther
Also called ICT implementations in the electronic patient file
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: education of guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: up to 1 year pre measurement and up to 1 year post measurement
Secondary outcomes (1)
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)
Measured: up to 1 year (post measurement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start1 Aug 2017
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Why it stopped: the pilot study (before the intervention) is completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood TransfusionStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- observational cross-sectional study with pre and post measurement and in between an interventional phase with education, IT implementations etc.
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Els Costermans, MD, Principal investigator, advanced clinical nurse specialist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217370
- Sponsor's protocol ID
- S60580
- Status last verified
- Feb 2019
- First submitted
- 5 Jul 2017
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Patient Blood Management in Haematological Patients
- ClinicalTrials.gov ID
- NCT03217370
- Acronym / sponsor ID
- S60580
- Conditions
- Blood Transfusion, Haematology
- Keywords
- patient blood management, restrictive transfusion
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: the pilot study (before the intervention) is completed.
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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), ...
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- observational cross-sectional study with pre and post measurement and in between an interventional phase with education, IT implementations etc.
| Arm | Type | Receives |
|---|---|---|
| all haematologists | Other | Other: education of guidelinesThere 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (3 listed)
- ambulatory patients
- patients without blood transfusion administered in their hospitalised period
- patients with no haematological illness that were hospitalised at the haematological wards
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| education of guidelinesAlso: ICT implementations in the electronic patient file* 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 | Other | all haematologists |
Primary outcome
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?
1 secondary outcome
what's the effect of the interventional phase?
Time frame: up to 1 year (post measurement)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Blood Transfusion
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 3
A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions
Myelodysplastic Syndromes
RecruitingPhase 3
A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Lower Risk Myelodysplastic Syndromes (LR-MDS) Who Need Regular Blood Transfusions
Myelodysplastic Syndrome, Anemia
Active, not recruiting
Evaluation the Safety and Efficacy of KL003 Cell Injection in the Treatment of Transfusion-dependent β-thalassemia.
Transfusion-dependent Beta-Thalassemia
RecruitingPhase 1/2
A Phase 1/2 Study to Evaluate the Safety and Efficacy of Dibotatug (DR-01) in Adults With Bone Marrow Failure Syndromes
Bone Marrow Failure Syndromes, Aplastic Anemias
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Els Costermans, MD principal investigator
advanced clinical nurse specialist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education of guidelines in people with Blood Transfusion and Haematology, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
how do haematologists prescribe blood components? (time frame: up to 1 year pre measurement and up to 1 year post measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2019.