- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03133351
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
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
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Saint Louis, Missouri, United States, 63110
- Washington University in St. Louis
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
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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:
- 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
Exclusion Criteria:
- 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
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:
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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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