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

April 15, 2020 updated by: Entegrion, Inc.
This study is intended to define the PCM normal laboratory range.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University in St. Louis
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PCM
All enrolled subjects will have a blood sample tested using PCM.
A fresh whole blood sample will be tested by PCM to determine the reference range.
Other Names:
  • Point of Care Coagulation Monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PCM Clotting Time (CT)
Time Frame: Testing to be initiated within 4 minutes of sample collection
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)
Time Frame: Testing to be initiated within 4 minutes of sample collection
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)
Time Frame: Testing to be initiated within 4 minutes of sample collection

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)
Time Frame: Testing to be initiated within 4 minutes of sample collection
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)
Time Frame: Testing to be initiated with 4 minutes of sample collection, with result available 30 minutes after CT
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)
Time Frame: Testing to be initiated within 4 minutes of sample collection, with result available 45 minutes after CT
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 4, 2017

Primary Completion (ANTICIPATED)

December 30, 2020

Study Completion (ANTICIPATED)

March 31, 2021

Study Registration Dates

First Submitted

April 6, 2017

First Submitted That Met QC Criteria

April 25, 2017

First Posted (ACTUAL)

April 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 16, 2020

Last Update Submitted That Met QC Criteria

April 15, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • PCM-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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