Adult MDW Dual Cut-Off Accuracy Study

Beckman Coulter

Status

Not yet enrolling

Conditions

Sepsis

Treatments

Diagnostic Test: Complete Blood Count with differential

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT06885528

D25391

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,225 estimated patients

Sex

All

Ages

18 to 89 years old

Volunteers

No Healthy Volunteers

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 <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).