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Terminated
NCT06885528
Adult MDW Dual Cut-Off Accuracy Study
Conditions: Sepsis
Sex: All
Ages: 18 Years – 89 Years
Healthy volunteers: No
Enrollment: 524
Sponsor: Beckman Coulter, Inc.
Location: Indiana University Indianapolis Indiana
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 patients in the Emergency Department (ED) for progression to sepsis.
Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* 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 \
Source: ClinicalTrials.gov (NCT06885528). StuddyBuddy aggregates publicly available trial information.