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

Status unconfirmed

Conditions studied: Coagulation

In brief

This study is intended to define the PCM normal laboratory range.

Key facts

Study ID

NCT03133351

Run by

Entegrion, Inc.

People needed

240

Starts

2017-04-04

Expected to finish

2021-03-31

Last updated by the study team

2020-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Washington University in St. Louis — St Louis, Missouri, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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