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

Coagulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03133351
• Other study ID #: PCM-001
• Status: Active, not recruiting
• Start date: April 4, 2017
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2020
• Source: Entegrion, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: March 31, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coagulation

Intervention

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

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Entegrion, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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