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

• Conditions: Coagulation
• Interventions: Device: PCM

• Registration Number: NCT03133351
• Lead Sponsor: Entegrion, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-04
• Study First Submitted: 2017-04-06
• Study First Submitted QC: 2017-04-25
• Study First Posted: 2017-04-28
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-15
• Last Update Posted: 2020-04-16
• Primary Completion: 2020-12-30
• Study Completion: 2021-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
PCM Clotting Time (CT)	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.
Clot Formation Time (CFT)	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.
Alpha Angle (AA)	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.
Maximum Clot Firmness (MCF)	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.
30-minutes Lysis after CT (LI30)	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.
45-minutes Lysis after CT (LI45)	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.

Trial Locations

Locations (2)

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States