Clinical Performance of the Investigational GEM Hemochron® 100 in Populations Ages 18 Years and Older

Status unconfirmed

Conditions studied: Blood Coagulation Test

In brief

This study is designed to evaluate and verify the clinical accuracy of the Hemochron® MCS 7000 Whole Blood Microcoagulation System; a point-of-care, whole blood Activated Clotting Time (ACT) measurement in comparison with the Hemochron Signature Elite® Whole Blood Microcoagulation System; a 510(k) cleared predicate device. This is a multi-center, prospective method comparison, with data to be analyzed separately from each site as well as combined for all sites.

Key facts

Study ID

NCT03074266

Run by

Accriva Diagnostics

People needed

140

Starts

2017-06-08

Expected to finish

2018-12-01

Last updated by the study team

2018-07-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Therapeutic Group
• Patients meeting all of the following criteria will be considered for entry into the study:
• Males and females 18 years or older.
• Patients scheduled for elective or urgent procedures requiring anticoagulation with UFH.
• Patients requiring heparin anticoagulant therapy for any approved indication and being managed and monitored with the ACT test.

You may not qualify if…

• The following criteria define the population of subjects who will not be accepted in the study:
• The subject develops a significant, unexpected, concurrent illness or adverse event before the first whole blood sample is drawn.
• The subject with a hematocrit of less than 20% or greater than 55% since these samples are not recommended for testing due to optical densities outside of the Hemochron instrument levels of detection.

Where it is running

• Accriva Study Site — Los Angeles, California, United States
• Accriva Study Site — Sacramento, California, United States
• Accriva Study Site — Aurora, Colorado, United States
• Accriva Study Site — Baltimore, Maryland, United States
• Accriva Study Site — Takoma Park, Maryland, United States
• Accriva Study Site — New Brunswick, New Jersey, United States
• Accriva Study Site — Chapel Hill, North Carolina, United States
• Accriva Study Site — Falls Church, Virginia, United States
• Accriva Study Site — Charleston, West Virginia, United States

Full record on ClinicalTrials.gov

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