Clinical Trial to Evaluate MDW for Early Detection of Sepsis

NCT06267742 | Active Not Recruiting FDA Device

• 1 other identifier: CHN097
• Study Type: observational
• Target: 2,200
• Locations: 1 country
• Sites: 3

Brief 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

Sepsis

Outcome Measures

Primary Outcomes (1)

• sensitivity, specificity

  sensitivity (percentage of patients with sepsis correctly identified), specificity (percentage of non-sepsis patients correctly identified) according to Sepsis-2

  2022.3-2024.3

Interventions

Complete Blood Count (CBC) with Differential DIAGNOSTIC_TEST

CBC with Differential including Monocyte Distribution Width (MDW)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of any race and ethnicity can be enrolled to this study. Patients with a prior chronic immunosuppressive disease and subjects with hematological malignancy can also be enrolled. This study requires at least 250 sepsis subjects and 1,100 non-sepsis subjects.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beckman Coulter, Inc.: lead
• Peking Union Medical College Hospital: collaborator
• West China Hospital: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator

Study Sites (3)

Peking Union Medical College Hospital

Beijing, China

Location

West China Hospital, Sichuan University

Chengdu, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China

Location

MeSH Terms

Conditions

Sepsis

Interventions

Blood Cell Count

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• DONG LI, MS

  BECKMAN COULTER

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 20, 2024
• Study Start: June 23, 2022
• Primary Completion: May 31, 2024
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)