AnemiaNCT05634005
Clinical Decision Support for Blood Transfusions to Improve Guideline Adherence
A study testing Clinical Decision Support in people with Anemia and Thrombocytopenia, run by University of Utah at 1 site in United States.
Trial summary
Determine whether clinical decision support (best practice advisory) improves provider adherence to transfusion guidelines for all four major blood components (red blood cells, plasma, platelets, and cryoprecipitate) using a randomized study design to reduce risk of bias. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Thrombocytopenia, Coagulopathy, Mild
- What is being tested?
- Clinical Decision Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,543 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 1 Feb 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ordering providers that order at least one blood product in the electronic health record
Who cannot join
- Any individual without privileges to place an initial order for blood product(s)
Trial locations and contacts
1 site in 1 country.
About this study
Determine whether clinical decision support (best practice advisory) improves provider adherence to transfusion guidelines for all four major blood components (red blood cells, plasma, platelets, and cryoprecipitate) using a randomized study design to reduce risk of bias. Alerts will be visible to the experimental ordering provider group, while they will not be visible to the control. Both groups still have access to information about best practices: local clinical transfusion guidelines are available and education on blood transfusion best practices will continue regardless of randomization assignment.
- Conditions
- Anemia, Thrombocytopenia, Coagulopathy, Mild, Hypofibrinogenemia
- Being tested
- Clinical Decision Support
- Keywords
- Transfusion, Clinical Decision Support
- Medical subject headings
- Anemia, Thrombocytopenia, Hemostatic Disorders, Lymphoma, Follicular, Afibrinogenemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decision SupportBehavioural
Also called Best Practice Advisory
In blood product order entry within the electronic health record, the ordering provider is required to select an indication for the blood product order. If the patient's laboratory values are not in line with the guideline indication selected, a clinical decision support alert will fire and be shown to the ordering provider. This alert will inform the provider that the order is outside institutional guidelines and the provider has the option to cancel the order (or bypass the order and select a reason for proceeding with the order).
| Study group | Role | What they receive |
|---|---|---|
| Ordering Providers Assigned to Visible Clinical Decision Support Alerts | Experimental | Clinical decision support alert will fire and become visible to the ordering provider in the electronic health record if blood product(s) are ordered out of accordance with guidelines. Information about transfusion guidelines and best practices will be sent to providers prior to starting the study and will be available on an internal website. Receives: Behavioral: Clinical Decision Support |
| Ordering Providers Assigned to No Visible Clinical Decision Support Alerts | No intervention | Clinical decision support alert will not be visible to the ordering provider in the electronic health record if blood product(s) are ordered out of accordance with guidelines. Information about transfusion guidelines and best practices will be sent to providers prior to starting the study and will be available on an internal website. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of blood components transfused that met clinical decision support alert criteria
Number of blood components transfused (includes red blood cell, platelet, plasma, and cryoprecipitate pools) that met criteria for clinical decision support alerts to fire
Measured: Through study completion, an average of 12 months
Secondary outcomes (4)
Number of red blood cell components transfused that met clinical decision support alert criteria
Number of red blood cell components transfused that met criteria for clinical decision support alerts to fire
Measured: Through study completion, an average of 12 months
Number of platelet components transfused that met clinical decision support alert criteria
Number of platelet components transfused that met criteria for clinical decision support alerts to fire
Measured: Through study completion, an average of 12 months
Number of plasma components transfused that met clinical decision support alert criteria
Number of plasma components transfused that met criteria for clinical decision support alerts to fire
Measured: Through study completion, an average of 12 months
Number of cryoprecipitate component pools transfused that met clinical decision support alert criteria
Number of cryoprecipitate component pools transfused that met criteria for clinical decision support alerts to fire
Measured: Through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start1 Feb 2023
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,543 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Metcalf, University of Utah
- Investigators
- Ryan Metcalf, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634005
- Sponsor's protocol ID
- IRB_00156498
- Status last verified
- Mar 2025
- First submitted
- 17 Oct 2022
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not planning to make individual participant data (IPD) available to other researchers.
Publications
Mueller MM, Van Remoortel H, Meybohm P, Aranko K, Aubron C, Burger R, Carson JL, Cichutek K, De Buck E, Devine D, Fergusson D, Follea G, French C, Frey KP, Gammon R, Levy JH, Murphy MF, Ozier Y, Pavenski K, So-Osman C, Tiberghien P, Volmink J, Waters JH, Wood EM, Seifried E; ICC PBM Frankfurt 2018 Group. Patient Blood Management: Recommendations From the 2018 Frankfurt Consensus Conference. JAMA. 2019 Mar 12;321(10):983-997. doi: 10.1001/jama.2019.0554.
PubMed 30860564
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Decision Support for Blood Transfusions to Improve Guideline Adherence
- ClinicalTrials.gov ID
- NCT05634005
- Acronym / sponsor ID
- IRB_00156498
- Conditions
- Anemia, Thrombocytopenia, Coagulopathy, Mild, Hypofibrinogenemia
- Keywords
- Transfusion, Clinical Decision Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,543 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 1 Dec 2022 (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.
Determine whether clinical decision support (best practice advisory) improves provider adherence to transfusion guidelines for all four major blood components (red blood cells, plasma, platelets, and cryoprecipitate) using a randomized study design to reduce risk of bias. Alerts will be visible to the experimental ordering provider group, while they will not be visible to the control. Both groups still have access to information about best practices: local clinical transfusion guidelines are available and education on blood transfusion best practices will continue regardless of randomization assignment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ordering Providers Assigned to Visible Clinical Decision Support Alerts | Experimental | Behavioral: Clinical Decision SupportClinical decision support alert will fire and become visible to the ordering provider in the electronic health record if blood product(s) are ordered out of accordance with guidelines. Information about transfusion guidelines and best practices will be sent to providers prior to starting the study and will be available on an internal website. |
| Ordering Providers Assigned to No Visible Clinical Decision Support Alerts | No intervention | –Clinical decision support alert will not be visible to the ordering provider in the electronic health record if blood product(s) are ordered out of accordance with guidelines. Information about transfusion guidelines and best practices will be sent to providers prior to starting the study and will be available on an internal website. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ordering providers that order at least one blood product in the electronic health record
Key exclusion criteria (1 listed)
- Any individual without privileges to place an initial order for blood product(s)
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 |
|---|---|---|
| Clinical Decision SupportAlso: Best Practice AdvisoryIn blood product order entry within the electronic health record, the ordering provider is required to select an indication for the blood product order. If the patient's laboratory values are not in line with the guideline indication selected, a clinical decision support alert will fire and be shown to the ordering provider. This alert will inform the provider that the order is outside institutional guidelines and the provider has the option to cancel the order (or bypass the order and select a reason for proceeding with the order). | Behavioural | Ordering Providers Assigned to Visible Clinical Decision Support Alerts |
Primary outcome
Number of blood components transfused that met clinical decision support alert criteria
Time frame: Through study completion, an average of 12 months
Number of blood components transfused (includes red blood cell, platelet, plasma, and cryoprecipitate pools) that met criteria for clinical decision support alerts to fire
4 secondary outcomes
Number of red blood cell components transfused that met clinical decision support alert criteria
Time frame: Through study completion, an average of 12 months
Number of platelet components transfused that met clinical decision support alert criteria
Time frame: Through study completion, an average of 12 months
Number of plasma components transfused that met clinical decision support alert criteria
Time frame: Through study completion, an average of 12 months
Number of cryoprecipitate component pools transfused that met clinical decision support alert criteria
Time frame: Through study completion, an average of 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Background: PubMed 30860564Mueller MM, Van Remoortel H, Meybohm P, Aranko K, Aubron C, Burger R, Carson JL, Cichutek K, De Buck E, Devine D, Fergusson D, Follea G, French C, Frey KP, Gammon R, Levy JH, Murphy MF, Ozier Y, Pavenski K, So-Osman C, Tiberghien P, Volmink J, Waters JH, Wood EM, Seifried E; ICC PBM Frankfurt 2018 Group. Patient Blood Management: Recommendations From the 2018 Frankfurt Consensus Conference. JAMA. 2019 Mar 12;321(10):983-997. doi: 10.1001/jama.2019.0554.
- Individual participant dataSharing planned: No. We are not planning to make individual participant data (IPD) available to other researchers.
Related trials for Anemia
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
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 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
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.
Ryan Metcalf, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Decision Support in people with Anemia and Thrombocytopenia, run by University of Utah at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 6 Mar 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of blood components transfused that met clinical decision support alert criteria (time frame: Through study completion, an average of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05634005, which also lists 1 linked publication.
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 6 Mar 2025.