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

Last updated: July 24, 2018
Sponsor: Accriva Diagnostics
Overall Status: Active - Enrolling

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03074266
HRZ-CSS-15-0002
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria: 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 withUFH.

  • Patients requiring heparin anticoagulant therapy for any approved indication and beingmanaged and monitored with the ACT test.

Exclusion

Exclusion Criteria: The following criteria define the population of subjects who will not be accepted in thestudy:

  • The subject develops a significant, unexpected, concurrent illness or adverse eventbefore the first whole blood sample is drawn.

  • The subject with a hematocrit of less than 20% or greater than 55% since these samplesare not recommended for testing due to optical densities outside of the Hemochroninstrument levels of detection.

Study Design

Total Participants: 140
Study Start date:
June 08, 2017
Estimated Completion Date:
December 31, 2018

Study Description

The study will be performed in the clinical setting by trained professional operators.

Group 1: Whole Blood Coagulation Test 1, GEM Hemochron® 100

Group 2: Whole Blood Coagulation Test 2, Hemochron® Signature Elite® 7000 Whole Blood Microcoagulation System

Ex-vivo whole blood samples destined for discard after all medically directed tests are complete will be used from heparinized patients undergoing standard of care interventional procedures in different clinical settings. These include, but are not limited to, the cardiovascular operating room (CVOR), cardiac catheterization lab, surgical intensive care unit (SICU), the electrophysiology (EP) lab, and in extracorporeal membrane oxygenation (ECMO) applications.

A distribution of ACT values is necessary to evaluate clinical accuracy. The target number of subjects for each site is 100.

Samples will be examined at baseline (pre-heparin administration) and at the end of the procedure. Heparinized samples may be obtained for ACT testing once or multiple times while heparin is administered throughout the duration of the procedure. The frequency and time intervals of ACT testing will be determined by the Standard of Care. No additional blood volume or extra blood draws will occur as the result of this study.

The work flow for the testing process will be consistent across all sites. Expected duration of the study is dependent upon the site logistics but generally is expected to last no more than four to six weeks.

ACT results generated from the GEM Hemochron 100 instrument during this study will be used solely for research purposes and will not be used for anticoagulation management of study subjects. No patient follow up is required.

The study will include two GEM Hemochron 100 instruments, trained operators, and two Signature Elite instruments for each procedure.

Guidance was obtained from Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline (CLSI POCT14-A), CLSI EP09-A3: "Method Procedure Comparison and Bias Estimation Using Patient Samples; Approved guideline Third Edition" and peer reviewed literature.

All study data will be collected on Case Report Forms and all analysis will be performed by Accriva.

Connect with a study center

  • Accriva Study Site

    Escondido, California 92029
    United States

    Site Not Available

  • Accriva Study Site

    Los Angeles, California 90033
    United States

    Site Not Available

  • Accriva Study Site

    Sacramento, California 95816
    United States

    Site Not Available

  • Accriva Study Site

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Accriva Study Site

    Baltimore, Maryland 21215
    United States

    Site Not Available

  • Accriva Study Site

    Takoma Park, Maryland 20912
    United States

    Site Not Available

  • Accriva Study Site

    New Brunswick, New Jersey 08903
    United States

    Site Not Available

  • Accriva Study Site

    Rochester, New York 14642
    United States

    Site Not Available

  • Accriva Study Site

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Accriva Study Site

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • Accriva Study Site

    Charleston, West Virginia 25304
    United States

    Site Not Available

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