Adult MDW Dual Cut-Off Accuracy Study

NCT06885528 | Not Yet Recruiting FDA Device

• 1 other identifier: D25391
• Study Type: observational
• Target: 2,225
• Locations: 0 countries
• Sites: N/A

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 patients in the Emergency Department (ED) for progression to sepsis.

Conditions

Sepsis

Keywords

Sepsis Diagnosis; MDW

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 1 year

Study Arms (1)

Adults presenting to Emergency Department

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

Interventions

Complete Blood Count with differential DIAGNOSTIC_TEST

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.

Adults presenting to Emergency Department

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All-comers study of adult patients (18 to 89 years) of all races and ethnicities presenting to the ED

You may qualify if:

• 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

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Beckman Coulter, Inc.: lead
• Indiana University Health: collaborator
• University of Kansas Medical Center: collaborator
• Hackensack Meridian Health: collaborator

Related Publications (1)

• Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G; International Sepsis Definitions Conference. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Intensive Care Med. 2003 Apr;29(4):530-8. doi: 10.1007/s00134-003-1662-x. Epub 2003 Mar 28.

  PMID: 12664219 BACKGROUND

MeSH Terms

Conditions

Sepsis

Interventions

Blood Cell Count

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Alicia Drain, BSc

  Beckman Coulter, Inc.

  STUDY DIRECTOR

Central Study Contacts

Iris Castro, PhD

CONTACT

7869324288; icastro@beckman.com

Sarah Kurtenbach, PhD

CONTACT

7869324288; skurtenbach@beckman.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 20, 2025
• Study Start: May 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share