Blood Transfusion Clinical Trial
Official title:
Blood Transfusion Reduction Quality Improvement Project
NCT number | NCT04823273 |
Other study ID # | 19-0918 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 6, 2021 |
Est. completion date | October 15, 2022 |
Verified date | May 2023 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Blood Banks of large medical centers have large annual budgets, typically millions of dollars. Blood product wastage results in not only in a loss of the product's cost, but also of the fees involved in transporting, handling, and administering these products. Optimal utilization of blood products requires a balance between maximizing patient clinical outcomes while avoiding unnecessary costs and risks associated with transfusions. This project will specifically focus on packed red blood cell transfusions (pRBCs). There are clear guidelines for transfusing pRBCs however these guidelines are not always followed. pRBC transfusions outside of recommended guidelines is associated with increased risk of harm to patients. Our aim is to improve adherence to guideline indicated pRBC transfusions for patient in the UCHealth system thereby decreasing inappropriate (non-guideline indicated) pRBC transfusions. We will conduct a QI project seeking to improve pRBC transfusion guideline adherence. This project will involve data review to establish baseline rates, multimodal interventions to improve adherence to pRBC transfusion guidelines including provider education, modifications to the electronic ordering interface, and changing blood back policies at participating institutions.
Status | Completed |
Enrollment | 1640 |
Est. completion date | October 15, 2022 |
Est. primary completion date | April 5, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - All physicians and nurses with access to order inpatient blood transfusions through a hospital-based EMR. - All physicians and nurses ordering blood for individuals over the age of 18. Exclusion Criteria: - All physicians and nurses ordering blood transfusion ordering blood in the OR - Blood ordered through massive transfusion protocol |
Country | Name | City | State |
---|---|---|---|
United States | UCHealth University of Colorado Hospital | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Historical Blood Transfusion Orders | Number of patients who received blood transfusions during the 18 months prior to study start in the EHR at the same hospital. | Baseline | |
Other | Historical Guideline Concordance Measured by Pre-Transfusion Hemoglobin Values Per Transfusion | The American Association of Blood Banks recommends a restrictive threshold of a pre-transfusion hemoglobin level of less than 7.0g/dL for the vast majority of inpatients. Historical data for 18 months prior to study start will be collected from EHR records for transfusions orders placed for patients with Hemoglobin levels above 7. | Baseline | |
Other | Guideline Concordance Measured by Number of Units Ordered Per Transfusion | The American Association of Blood Banks recommends a restrictive threshold of a single unit pRBC transfusion for the vast majority of inpatients. Historical data for 18 months prior to study start will be collected from EHR records for the number of units transfused per blood transfusion order. | Baseline | |
Primary | Blood Transfusion Orders | Number of patients who received blood transfusions during the study by arm. | 78 weeks | |
Primary | Guideline Concordance Measured by Pre-Transfusion Hemoglobin Values Per Transfusion | The American Association of Blood Banks recommends a restrictive threshold of a pre-transfusion hemoglobin level of less than 7.0g/dL for the vast majority of inpatients. Transfusions with Hemoglobin levels above 7 will be compared in arm 1 vs 2 +3 combined; arm 2 vs arm 3. | 78 weeks | |
Primary | Guideline Concordance Measured by Number of Units Ordered Per Transfusion | The American Association of Blood Banks recommends a restrictive threshold of a single unit pRBC transfusion for the vast majority of inpatients. This outcome will compare hemoglobin levels, units transfused in arm 1 verses arms 2 and 3 combined and arm 2 verses arm 3. | 78 weeks |
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