Coagulation
Conditions
Brief summary
This study is intended to define the PCM normal laboratory range.
Interventions
DEVICEPCM
A fresh whole blood sample will be tested by PCM to determine the reference range.
Sponsors
Entegrion, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age ≥ 18 years old 2. Body Mass Index (BMI) ≥ 19 and ≤ 30 kg/m2m with body weight ≥ 50 kg (106 lb) 3. Normal vital signs at screening
Exclusion criteria
1. Current daily tobacco use or previous recreational drug use 2. Pregnant or lactating at the time of the study 3. Currently taking any medications known to affect coagulation 4. 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 5. Current diagnosis of cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PCM Clotting Time (CT) | Testing to be initiated within 4 minutes of sample collection | To define the PCM normal laboratory reference range, PCM clotting time (CT) will be measured. |
| Clot Formation Time (CFT) | Testing to be initiated within 4 minutes of sample collection | To define the PCM normal laboratory reference range, clot formation time (CFT) will be measured. |
| Alpha Angle (AA) | Testing to be initiated within 4 minutes of sample collection | 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. |
| Maximum Clot Firmness (MCF) | Testing to be initiated within 4 minutes of sample collection | To define the PCM normal laboratory reference range, maximum clot firmness (MCF) will be measured. |
| 30-minutes Lysis after CT (LI30) | Testing to be initiated with 4 minutes of sample collection, with result available 30 minutes after CT | To define the PCM normal laboratory reference range, 30-minutes lysis after CT (LI30) will be measured. |
| 45-minutes Lysis after CT (LI45) | Testing to be initiated within 4 minutes of sample collection, with result available 45 minutes after CT | To define the PCM normal laboratory reference range, 45-minutes lysis after CT (LI45) will be measured. |
Countries
United States
Outcome results
None listed