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Not yet recruiting NCT06885528

Adult MDW Dual Cut-Off Accuracy Study

— Observational Sepsis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Complete Blood Count with differential.
Who it may be relevant to
Registry conditions: Sepsis. Basic parameters: 18 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Clinical performance of MDW [Time frame: through study completion, an average of 1 year]

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 <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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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

Identifiers

NCT: NCT06885528 · D25391

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗