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| Name | Class |
|---|---|
| Peking Union Medical College Hospital | OTHER |
| West China Hospital | OTHER |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Complete Blood Count (CBC) with Differential | Diagnostic Test | CBC with Differential including Monocyte Distribution Width (MDW) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| DONG LI, MS | BECKMAN COULTER | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | China | ||||
| West China Hospital, Sichuan University |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D001772 | Blood Cell Count |
| ID | Term |
|---|---|
| D002452 | Cell Count |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| Chengdu |
| China |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | China |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D006403 | Hematologic Tests |
| D008919 | Investigative Techniques |
| D002468 | Cell Physiological Phenomena |
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |