Status:
NOT_YET_RECRUITING
Adult MDW Dual Cut-Off Accuracy Study
Lead Sponsor:
Beckman Coulter, Inc.
Collaborating Sponsors:
Indiana University Health
University of Kansas Medical Center
Conditions:
Sepsis
Eligibility:
All Genders
18-89 years
Brief Summary
This study will establish the clinical performance of the Monocyte Distribution Width (MDW) parameter on the DxH 900/ DxH 690T hematology analyzers to aid in the detection and risk assessment of patie...
Detailed Description
The objective of this study is to validate the MDW dual cut-off values established during characterization and demonstrate the performance of MDW to detect sepsis in a multi-center study of adults pre...
Eligibility Criteria
Inclusion
- Adults (18 to 89 years) of all races and ethnicities presenting to the ED
- Whole Blood venous samples collected in K2EDTA while the patient was in the ED
- First CBC w/diff test ordered within 12 hours of presentation to ED as part of their standard medical care
- CBC w/diff tested within 2 hours of specimen collection
- Subjects with at least ≥12 hours of follow-up in the ED (or inpatient, if admitted) from presentation
Exclusion
- CBC w/diff test ordered after 12 hours of presentation to ED
- Subjects previously enrolled in this study (i.e. subjects may not be enrolled more than once in this study)
- Subjects discharged from ED \<12 hours from ED presentation
- ED Transfer Patients
- Data Exclusions Post Enrollment:
- Samples that have a system generated flag from the Standard of Care (SOC) CBC w/diff testing will be excluded.
- Samples with instrument flags, including vote outs and review flags for MDW will also be excluded (i.e. invalid MDW results).
- Subjects' data collected with Instrument Quality Control failure(s).
Key Trial Info
Start Date :
May 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
2225 Patients enrolled
Trial Details
Trial ID
NCT06885528
Start Date
May 1 2025
End Date
June 1 2026
Last Update
March 20 2025
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