Clinical Trial to Evaluate MDW for Early Detection of Sepsis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

2200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-23

Study Completion Date

2026-09-30

Brief Summary

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This study is intended to clinically verify Monocyte Distribution Width (MDW) parameter of DxH 900 Hematology Analyzer for use in early detection and risk assessment of sepsis, severe sepsis, and septic shock in critically ill patients in Emergency Department (ED). This study is also aimed to provide study supporting data for the product to be marketed in China.

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Detailed Description

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To verify the clinical performance of MDW parameter in detection of sepsis through a multicenter, prospective study of adults undergoing complete blood count with differential ("CBC with differential") in the ED.

To clarify the cutoff 20.0 established in the pivotal trial. The cutoff was established for the objective of achieving the highest sensitivity at the optimal specificity level. Patients whose MDW value is higher than the cutoff will be identified as sepsis patients and those whose MDW value is equal to or lower than the cutoff are non-sepsis patients.

Conditions

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Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Complete Blood Count (CBC) with Differential

CBC with Differential including Monocyte Distribution Width (MDW)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Adult subjects (18-89 years) presenting to ED.
* CBC with Differential performed upon presentation as part of standard of care.
* Subject scheduled for at least 12 hours follow-up during ED (or inpatient, if admitted to the hospital) visit
* Signed the informed consent form

Exclusion Criteria

* Subjects previously enrolled in this study (i.e., re-enrollment to this study is not allowed).
* The subject is discharged from the hospital within 12 hours after ED visit

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No