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

NCT03133351 | Unknown FDA Device

• 1 other identifier: PCM-001
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Coagulation

Outcome Measures

Primary Outcomes (6)

• PCM Clotting Time (CT)

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

  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.

  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.

  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.

  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.

  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.

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

Study Arms (1)

PCM

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

Device: PCM

Interventions

PCM DEVICE

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

Also known as: Point of Care Coagulation Monitor

PCM

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 120 Males and 120 Females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers

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

Sponsors & Collaborators

• Entegrion, Inc.: lead

Study Sites (2)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 28, 2017
• Study Start: April 4, 2017
• Primary Completion: December 30, 2020
• Study Completion: March 31, 2021
• Last Updated: April 16, 2020

Record last verified: 2020-04

Locations

US (2)