Red Blood Cell TransfusionsTRIPNCT07108374
Implementation of Red Blood Cell Transfusion Recommendations in the Pediatric Intensive Care Unit
A study testing Implementation strategies to increase use of transfusion recommendations in people with Red Blood Cell Transfusions, run by Stanford University at 2 sites in United States.
Trial summary
Evidence demonstrates that the risks of red blood cell transfusions outweigh benefits in many patients who are hospitalized in the pediatric intensive care unit with increased risk of organ dysfunction, infection, delirium, and death. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Red Blood Cell Transfusions
- What is being tested?
- Implementation strategies to increase use of transfusion recommendations
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Nov 2024to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Employed at Lucile Packard Children's Hospital at Stanford University or the Children's Hospital of Philadelphia AND
- Employed in one of the following roles:
- PICU nurse
- PICU attending
- PICU fellow
- PICU resident
Show all 12Show fewer
- PICU advanced practice provider
- Other physician or surgeon in subspecialties whose patients regularly receive transfusions in the PICU
- PICU TRIP implementation team member
- PICU nursing leader
- PICU physician leader
- Bood bank leader.
Who cannot join
- Unwilling to participate
- Directly report to the primary investigator.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Lucile Packard Children's Hospital, Stanford University
Palo Alto, California, 94304
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Transfusion Recommendations Implemented in the PICU (TRIP)
Evidence demonstrates that the risks of red blood cell transfusions outweigh benefits in many patients who are hospitalized in the pediatric intensive care unit with increased risk of organ dysfunction, infection, delirium, and death. Recommendations have been developed to restrict transfusion in patients who are unlikely to benefit; however, these recommendations have not been consistently adopted into clinical practice. This study examines use of targeted efforts (implementation strategies) to improve implementation of the recommendations, with a goal of reducing unnecessary transfusions and improving patient outcomes in critically ill children.
- Conditions
- Red Blood Cell Transfusions
- Being tested
- Implementation strategies to increase use of transfusion recommendations
- Keywords
- Red blood cell transfusions, Pediatric critical care medicine, Implementation Science, Clinical Recommendations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation strategies to increase use of transfusion recommendationsOther
Five implementation strategies will be employed in this study to enhance use of the blood transfusion recommendations. These include 1) building consensus, 2) provider education, 3) identifying and empowering champions ,4) use of computerized clinical decision support tools, and 5) provide quantitative metric-based feedback. Strategies 1-3 will occur prior to initiation of CCDS tools. All patients admitted to the PICU following the date of CCDS tool initiation will be considered to be part of the post-implementation phase. The investigators will collect data from the EHR on CCDS use and conduct provider surveys and interviews following CCDS tool initiation. Surveys and interviews will be both be conducted at 6 and 12 months post-CCDS tool initiation. Process and outcomes measures will be assessed before an after use of the implementation strategies.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in transfusion recommendation adherence at 18 months (evidence-based threshold alert)
The investigators will assess the mean rate of nonadherent transfusions at monthly intervals in the pre- (12 months prior to CCDS tool initiation) and post-implementation period (18 months following CCDS tool initiation).
Measured: 18 months
Secondary outcomes (2)
Mean change from baseline in transfusion recommendation adherence at 18 months (transfusions that require clinical judgement)
The investigators will assess the mean rate of nonadherent transfusions at monthly intervals in the pre- (12 months prior to CCDS tool initiation) and post-implementation period (18 months following CCDS tool initiation) for transfusions that require provider clinical judgement. Data analysis will be exploratory.
Measured: 18 months
Reach of computerized clinical decision support (CCDS) tools
We will assess Reach of the CCDS tools by assessing the number of triggered CCDS alerts as compared with the total number of patients at risk for unnecessary transfusion (as determined through the PEDSnet database under IRB 16-012878, PEDSnet Master Secondary Use Protocol, under amendment 96, Appendix 28).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start30 Nov 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Red Blood Cell TransfusionsStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study is best characterized as an interventional prospective cohort study. The investigators will deploy 5 implementation strategies intended to increase use of the red blood cell transfusion recommendations in two pediatric intensive care units. While all strategies will all be used, the investigators anticipate that implementation of the Computerized Clinical Decision Support (CCDS) tools will pose the greatest operational challenges in future studies and thus the focus of this study is on the implementation evaluation of these CCDS tools using an implementation framework (RE-AIM) customized for clinical informatics interventions. The investigators will prospectively evaluate the CCDS tools using the RE-AIM framework using a mixed methods approach that includes data collection from the Electronic Health Record (EHR) based on CCDS use, provider surveys, and data from brief, focused provider interviews.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Lucile Packard Children's Hospital, Children's Hospital of Philadelphia, Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Katherine M. Steffen, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108374
- Sponsor's protocol ID
- 70193
- Other IDs
- HS029298-03
- Acronym
- TRIP
- Status last verified
- Jul 2025
- First submitted
- 27 Jun 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because PEDSnet is not a public data repository, individual-level datasets are not typically released publicly outside of the network. Due to the complexity and privacy concerns associated with electronic health record data, certified PEDSnet data scientists lead the execution of all data analyses. While the data generated for this study cannot be shared publicly, our study team will make every effort to assist interested investigators and teams in leveraging the PEDSnet network to collaborate to obtain the entire dataset from this study or subset of data necessary for conducting secondary analyses or in answering a new, intended study question. Our study team will provide a final report(s) on our research findings and the investigators will relate that data can be made available for subsequent analyses through PEDSnet and provide necessary contact information to submit a Collaboration Request through PEDSnet or Dr. Steffen.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfusion Recommendations Implemented in the PICU (TRIP)
- ClinicalTrials.gov ID
- NCT07108374
- Acronym / sponsor ID
- TRIP / 70193
- Conditions
- Red Blood Cell Transfusions
- Keywords
- Red blood cell transfusions, Pediatric critical care medicine, Implementation Science, Clinical Recommendations
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Lucile Packard Children's Hospital, Children's Hospital of Philadelphia, Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 30 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 7 Aug 2025 (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.
Evidence demonstrates that the risks of red blood cell transfusions outweigh benefits in many patients who are hospitalized in the pediatric intensive care unit with increased risk of organ dysfunction, infection, delirium, and death. Recommendations have been developed to restrict transfusion in patients who are unlikely to benefit; however, these recommendations have not been consistently adopted into clinical practice. This study examines use of targeted efforts (implementation strategies) to improve implementation of the recommendations, with a goal of reducing unnecessary transfusions and improving patient outcomes in critically ill children.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- This study is best characterized as an interventional prospective cohort study. The investigators will deploy 5 implementation strategies intended to increase use of the red blood cell transfusion recommendations in two pediatric intensive care units. While all strategies will all be used, the investigators anticipate that implementation of the Computerized Clinical Decision Support (CCDS) tools will pose the greatest operational challenges in future studies and thus the focus of this study is on the implementation evaluation of these CCDS tools using an implementation framework (RE-AIM) customized for clinical informatics interventions. The investigators will prospectively evaluate the CCDS tools using the RE-AIM framework using a mixed methods approach that includes data collection from the Electronic Health Record (EHR) based on CCDS use, provider surveys, and data from brief, focused provider interviews.
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Employed at Lucile Packard Children's Hospital at Stanford University or the Children's Hospital of Philadelphia AND
- Employed in one of the following roles:
- PICU nurse
- PICU attending
- PICU fellow
Key exclusion criteria (2 listed)
- Unwilling to participate
- Directly report to the primary investigator.
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 |
|---|---|---|
| Implementation strategies to increase use of transfusion recommendationsFive implementation strategies will be employed in this study to enhance use of the blood transfusion recommendations. These include 1) building consensus, 2) provider education, 3) identifying and empowering champions ,4) use of computerized clinical decision support tools, and 5) provide quantitative metric-based feedback. Strategies 1-3 will occur prior to initiation of CCDS tools. All patients admitted to the PICU following the date of CCDS tool initiation will be considered to be part of the post-implementation phase. The investigators will collect data from the EHR on CCDS use and conduct provider surveys and interviews following CCDS tool initiation. Surveys and interviews will be both be conducted at 6 and 12 months post-CCDS tool initiation. Process and outcomes measures will be assessed before an after use of the implementation strategies. | Other | – |
Primary outcome
Mean change from baseline in transfusion recommendation adherence at 18 months (evidence-based threshold alert)
Time frame: 18 months
The investigators will assess the mean rate of nonadherent transfusions at monthly intervals in the pre- (12 months prior to CCDS tool initiation) and post-implementation period (18 months following CCDS tool initiation).
2 secondary outcomes
Mean change from baseline in transfusion recommendation adherence at 18 months (transfusions that require clinical judgement)
Time frame: 18 months
Reach of computerized clinical decision support (CCDS) tools
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: No. Because PEDSnet is not a public data repository, individual-level datasets are not typically released publicly outside of the network. Due to the complexity and privacy concerns associated with electronic health record data, certified PEDSnet data scientists lead the execution of all data analyses. While the data generated for this study cannot be shared publicly, our study team will make every effort to assist interested investigators and teams in leveraging the PEDSnet network to collaborate to obtain the entire dataset from this study or subset of data necessary for conducting secondary analyses or in answering a new, intended study question. Our study team will provide a final report(s) on our research findings and the investigators will relate that data can be made available for subsequent analyses through PEDSnet and provide necessary contact information to submit a Collaboration Request through PEDSnet or Dr. Steffen.
Related trials for Red Blood Cell Transfusions
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
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
RecruitingObservational study
First-Line Luspatercept in Transfusion-Dependent Lower-Risk Myelodysplastic Neoplasms
Myelodysplastic Neoplasms
Not yet recruiting
Hypoxic Red Blood Cells in Sickle Cell Anemia
Sickle Cell Anaemia, Sickle Cell Anemia Crisis
Recruiting
Blood Transfusion Strategies During Major Surgery
Perioperative Red Blood Cell Transfusion
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation strategies to increase use of transfusion recommendations in people with Red Blood Cell Transfusions, run by Stanford University at 2 sites 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 12 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Mean change from baseline in transfusion recommendation adherence at 18 months (evidence-based threshold alert) (time frame: 18 months). 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 7 Aug 2025.