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