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

Entegrion

Status: Unknown

Conditions: Coagulation

Treatments: Device: PCM

Study type: Observational

Funder types: Industry

Identifiers

NCT03133351

PCM-001

Details and patient eligibility

About

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

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

240 participants in 1 patient group

PCM

Description:

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

Treatment:

Device: PCM