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Clinical Trial to Evaluate MDW for Early Detection of Sepsis

NCT06267742 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2200

Last updated 2025-03-06

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Complete Blood Count (CBC) with Differential

CBC with Differential including Monocyte Distribution Width (MDW)

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    collaborator OTHER

  • West China Hospital

    collaborator OTHER

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    collaborator OTHER

  • Beckman Coulter, Inc.

    lead INDUSTRY

Principal Investigators

  • DONG LI, MS · BECKMAN COULTER

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-23
Primary Completion
2024-05-31
Completion
2026-09-30
FDA Device
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06267742 on ClinicalTrials.gov