An observational study in Sepsis, sponsored by Beckman Coulter, Inc.. Terminated at 5 sites in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Beckman Coulter, Inc. (part of Danaher Corporation) · Observational
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.
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 presenting to the ED who have CBC w/diff ordered within 12 hours of presentation.
This study is designed to enroll all-comers from selected sites that currently have a DxH 900 in use as part of routine testing in the ED. All subjects who meet the Inclusion Criteria will be included in the study, without enrichment. Data from all subjects meeting the Inclusion Criteria will be provided to a panel of independent adjudicators. Adjudicators will be blinded to the MDW result and any sepsis diagnostic determinations which may or may not be in the original medical record.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's enrollment of 524 is above the median of 150 across 1,162 observational studies indexed under Sepsis.
Browse Sepsis studies →Beckman Coulter, Inc. is the lead sponsor of 31 studies on the registry; 1 is open to participants now.
First submitted after Beckman Coulter, Inc. became part of Danaher Corporation.
Counted across the registry records on this site, refreshed daily.
All-comers study of adult patients (18 to 89 years) of all races and ethnicities presenting to the ED
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Exclusion Criteria:
Data Exclusions Post Enrollment:
All-comers study of adults (18 to 89 years) of all races and ethnicities presenting to the Emergency Department
Diagnostic Test: Complete Blood Count with differential
First CBC w/diff test ordered within 12 hours of presentation to ED as part of standard medical care. The MDW result will be used as diagnostic marker to predict the risk of developing sepsis.
Clinical performance of MDW
Clinical performance of MDW (expressed in terms of its interpretation bands and likelihood ratios) in diagnosing sepsis determined by clinical adjudication.
Time frame: through study completion, an average of 1 year
Plan to share: No
Ran from Jun 2025 to primary completion in Jul 2026, 12 months.
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This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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