Reference Range Analysis of the Entegrion Point of Care Coagulation Monitor (PCM™) in Healthy Volunteers
Status: | Active, not recruiting |
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Conditions: | Hematology |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/3/2019 |
Start Date: | April 4, 2017 |
End Date: | December 31, 2019 |
This study is intended to define the PCM normal laboratory range.
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
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