Reference Range Analysis of the Entegrion Point of Care Coagulation Monitor (PCM™) in Healthy Volunteers

Study Overview
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Brief Summary
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This study is intended to define the PCM normal laboratory range.

Official Title
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Reference Range Analysis of the Entegrion Point of Care Coagulation Monitor (PCM™) in Healthy Volunteers

Conditions
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Coagulation

Intervention / Treatment
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* Device: PCM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old Body Mass Index (BMI) ≥ 19 and ≤ 30 kg/m2m with body weight ≥ 50 kg (106 lb) Normal vital signs at screening Exclusion Criteria: Current daily tobacco use or previous recreational drug use Pregnant or lactating at the time of the study Currently taking any medications known to affect coagulation History of excessive bleeding from minor trauma that required medical attention, spontaneous nose bleeds that required medical attention or multiple spontaneous abortions, liver disease, blood related diseases, congenital or acquired coagulopathies or thromboembolic diseases Current diagnosis of cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCM<br>All enrolled subjects will have a blood sample tested using PCM. | Device: PCM<br>* A fresh whole blood sample will be tested by PCM to determine the reference range.<br>* Other names: Point of Care Coagulation Monitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCM Clotting Time (CT) | To define the PCM normal laboratory reference range, PCM clotting time (CT) will be measured. | Testing to be initiated within 4 minutes of sample collection | 
| Clot Formation Time (CFT) | To define the PCM normal laboratory reference range, clot formation time (CFT) will be measured. | Testing to be initiated within 4 minutes of sample collection | 
| Alpha Angle (AA) | To define the PCM normal laboratory reference range, alpha angle (AA) will be measured. To define the PCM normal laboratory reference range, clot formation time (CFT) will be measured. | Testing to be initiated within 4 minutes of sample collection | 
| Maximum Clot Firmness (MCF) | To define the PCM normal laboratory reference range, maximum clot firmness (MCF) will be measured. | Testing to be initiated within 4 minutes of sample collection | 
| 30-minutes Lysis after CT (LI30) | To define the PCM normal laboratory reference range, 30-minutes lysis after CT (LI30) will be measured. | Testing to be initiated with 4 minutes of sample collection, with result available 30 minutes after CT | 
| 45-minutes Lysis after CT (LI45) | To define the PCM normal laboratory reference range, 45-minutes lysis after CT (LI45) will be measured. | Testing to be initiated within 4 minutes of sample collection, with result available 45 minutes after CT |