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

N/AUnknownNCT03133351

Entegrion, Inc.240 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

240

Conditions

Coagulation

Interventions

PCMDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Washington University in St. Louis

St Louis, Missouri, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

PCM Clotting Time (CT)

To define the PCM normal laboratory reference range, PCM clotting time (CT) will be measured.

Time frame: Testing to be initiated within 4 minutes of sample collection

Clot Formation Time (CFT)

To define the PCM normal laboratory reference range, clot formation time (CFT) will be measured.

Time frame: Testing to be initiated within 4 minutes of sample collection

Alpha Angle (AA)

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.

Time frame: Testing to be initiated within 4 minutes of sample collection

Maximum Clot Firmness (MCF)

To define the PCM normal laboratory reference range, maximum clot firmness (MCF) will be measured.

Time frame: Testing to be initiated within 4 minutes of sample collection

30-minutes Lysis after CT (LI30)

To define the PCM normal laboratory reference range, 30-minutes lysis after CT (LI30) will be measured.

Time frame: Testing to be initiated with 4 minutes of sample collection, with result available 30 minutes after CT

45-minutes Lysis after CT (LI45)

To define the PCM normal laboratory reference range, 45-minutes lysis after CT (LI45) will be measured.

Time frame: Testing to be initiated within 4 minutes of sample collection, with result available 45 minutes after CT

Data from ClinicalTrials.gov

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