NCT06885528

Adult MDW Dual Cut-Off Accuracy Study

UniCel DxH 900/690T Monocyte Distribution Width (MDW) Dual Cut-Off Clinical Accuracy Protocol

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,225 (estimated)
• Sponsor: Beckman Coulter, Inc. · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Sepsis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-03-01
• Completion: 2026-06-01
• First posted: 2025-03-20
• Last updated: 2025-03-20

Regulatory

• FDA-regulated device study