SepsisMDWNCT06885528
Adult MDW Dual Cut-Off Accuracy Study
An observational study of Sepsis, run by Beckman Coulter, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Complete Blood Count with differential
- How many people
- 524 participants
- Where
- 5 sitesUnited States
- Study dates
- 12 Jun 2025to 8 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All-comers study of adult patients (18 to 89 years) of all races and ethnicities presenting to the ED
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Henry Ford Health System
Detroit, Michigan, 48202
Hackensack University Medical center
Hackensack, New Jersey, 07601
Indiana University
Indianapolis, Indiana, 46202
Kansas University Medical Center
Kansas City, Kansas, 66160
Truman Medical Center
Kansas City, Missouri, 64108
About this study
Official title: UniCel DxH 900/690T Monocyte Distribution Width (MDW) Dual Cut-Off Clinical Accuracy Protocol
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.
Read the 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
- Being tested
- Complete Blood Count with differential
- Keywords
- Sepsis Diagnosis, MDW
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete Blood Count with differentialDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Adults presenting to Emergency Department | All-comers study of adults (18 to 89 years) of all races and ethnicities presenting to the Emergency Department Receives: Diagnostic Test: Complete Blood Count with differential |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start12 Jun 2025
- Primary completion8 Jul 2026
- Study completion8 Jul 2026
Why it stopped: The study was discontinued due to a change in the company's strategic priorities for its hematology platform and was not related to concerns regarding the clinical performance, validity, or safety of MDW.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 524 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beckman Coulter, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Indiana University Health, University of Kansas Medical Center, Hackensack Meridian Health
- Responsible party
- Sponsor
- Investigators
- Alicia Drain, BSc, Study director, Beckman Coulter, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885528
- Sponsor's protocol ID
- D25391
- Acronym
- MDW
- Status last verified
- Aug 2026
- First submitted
- 13 Mar 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 12664219
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UniCel DxH 900/690T Monocyte Distribution Width (MDW) Dual Cut-Off Clinical Accuracy Protocol
- ClinicalTrials.gov ID
- NCT06885528
- Acronym / sponsor ID
- MDW / D25391
- Conditions
- Sepsis
- Keywords
- Sepsis Diagnosis, MDW
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was discontinued due to a change in the company's strategic priorities for its hematology platform and was not related to concerns regarding the clinical performance, validity, or safety of MDW.
- Enrolment
- 524 participants (actual)
- Lead sponsor
- Beckman Coulter, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Indiana University Health, University of Kansas Medical Center, Hackensack Meridian Health
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 8 Jul 2026 (actual)
- Study completion
- 8 Jul 2026 (actual)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults presenting to Emergency Department | – | Diagnostic Test: Complete Blood Count with differentialAll-comers study of adults (18 to 89 years) of all races and ethnicities presenting to the Emergency Department |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All-comers study of adult patients (18 to 89 years) of all races and ethnicities presenting to the ED
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complete Blood Count with differentialFirst 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. | Diagnostic test | Adults presenting to Emergency Department |
Primary outcome
Clinical performance of MDW
Time frame: through study completion, an average of 1 year
Clinical performance of MDW (expressed in terms of its interpretation bands and likelihood ratios) in diagnosing sepsis determined by clinical adjudication.
Results and safety
The study was stopped early (reason given: The study was discontinued due to a change in the company's strategic priorities for its hematology platform and was not related to concerns regarding the clinical performance, validity, or safety of MDW.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Background: PubMed 12664219Levy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alicia Drain, BSc study director
Beckman Coulter, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Beckman Coulter, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was discontinued due to a change in the company's strategic priorities for its hematology platform and was not related to concerns regarding the clinical performance, validity, or safety of MDW.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance of MDW (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06885528, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.