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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-04

Study Completion Date

2021-03-31

Brief Summary

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

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Detailed Description

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Conditions

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Coagulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PCM

All enrolled subjects will have a blood sample tested using PCM.

PCM

Intervention Type DEVICE

A fresh whole blood sample will be tested by PCM to determine the reference range.

Interventions

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PCM

A fresh whole blood sample will be tested by PCM to determine the reference range.

Intervention Type DEVICE

Other Intervention Names

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Point of Care Coagulation Monitor

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes