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Clinical Trial to Evaluate MDW for Early Detection of Sepsis
Sponsor: Beckman Coulter, Inc.
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.
Official title: Clinical Trial to Evaluate Early Sepsis Indicator Monocyte Distribution Width (MDW) for Early Detection of Sepsis or Developing Sepsis
Key Details
Gender
All
Age Range
18 Years - 89 Years
Study Type
OBSERVATIONAL
Enrollment
2200
Start Date
2022-06-23
Completion Date
2026-09-30
Last Updated
2025-03-06
Healthy Volunteers
No
Conditions
Interventions
Complete Blood Count (CBC) with Differential
CBC with Differential including Monocyte Distribution Width (MDW)
Locations (3)
Peking Union Medical College Hospital
Beijing, China
West China Hospital, Sichuan University
Chengdu, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China