Clinical Trial

Clinical Trial to Evaluate MDW for Early Detection of Sepsis

Active, Not Recruiting
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-02-12; most recent amendment 2025-03-05.
Status change: Recruiting → Active, Not Recruiting 2025-03-05
Trial Details
NCT Number NCT06267742
Lead Sponsor Beckman Coulter, Inc.
Collaborators: Peking Union Medical College Hospital, West China Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine
Conditions Sepsis
Enrollment 2,200 participants
Start Date 2022-06-23
Primary Completion 2024-05-31 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-03-06