Clinical Trial: Reference Range Analysis of the Entegrion Point of Care Coagulation Monitor (PCM™) in Healthy Volunteers
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Reference Range Analysis of the Entegrion Point of Care Coagulation Monitor (PCM™) in Healthy Volunteers
Brief Summary: This study is intended to define the PCM normal laboratory range.
Detailed Summary:
Sponsor: Entegrion, Inc.
Current Primary Outcome:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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&nb
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Entegrion, Inc.
Dates:
Date Received: April 6, 2017
Date Started: April 4, 2017
Date Completion: December 31, 2017
Last Updated: April 25, 2017
Last Verified: April 2017