Implementation of Red Blood Cell Transfusion Recommendations in the Pediatric Intensive Care Unit

Not Applicable

• Conditions: Red Blood Cell Transfusions

• Registration Number: NCT07108374
• Lead Sponsor: Stanford University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-30
• Study First Submitted: 2025-06-27
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-30
• Last Update Submitted: 2025-07-30
• Study First Posted: 2025-08-07
• Last Update Posted: 2025-08-07
• Primary Completion: 2026-12-31
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 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
• 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.

Exclusion Criteria

• Unwilling to participate
• Directly report to the primary investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in transfusion recommendation adherence at 18 months (evidence-based threshold alert)	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).

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in transfusion recommendation adherence at 18 months (transfusions that require clinical judgement)	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) for transfusions that require provider clinical judgement. Data analysis will be exploratory.
Reach of computerized clinical decision support (CCDS) tools	18 months	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).

Trial Locations

Locations (2)

Lucile Packard Children's Hospital, Stanford University; 🇺🇸 Palo Alto, California, United States

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States