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

NCT03074266 | Unknown FDA Device

• 1 other identifier: HRZ-CSS-15-0002
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Blood Coagulation Test

Outcome Measures

Primary Outcomes (1)

• Hemochron® MCS 7000 Whole Blood Microcoagulation System ACT measurements (time of whole blood coagulation in seconds) are clinically equivalent to those of the Hemochron Signature Elite® Whole Blood Microcoagulation System

  Demonstrate that the Hemochron® MCS 7000 Whole Blood Microcoagulation System Activated Clotting Time (ACT) measurements (time of whole blood coagulation in seconds) are clinically equivalent to those of the Hemochron Signature Elite® Whole Blood Microcoagulation System; a 510(k) cleared predicate device

  Therapeutic: 1 day; Normal: 1 day (duration of a single venous blood collection)

Study Arms (2)

Blood coagulation test 1

Therapeutic: Waste blood from heparinized patients undergoing interventional procedures (standard of care) in different clinical settings will be used to conduct coagulation tests using GEM Hemochron 100 during the course of the procedure before ("baseline") and after heparin administration. There is no drug administration or therapeutic intervention in this study. The interventional procedure (described above) is standard of care and all results of blood coagulation testing using GEM Hemochron 100 performed in this study are not used to influence that care.

Diagnostic Test: GEM Hemochron 100 ACT

Blood coagulation test 2

Therapeutic: Waste blood from heparinized patients undergoing interventional procedures (standard of care) in different clinical settings will be used to conduct duplicate coagulation tests using Signature Elite during the course of the procedure before ("baseline") and after heparin administration. There is no drug administration or therapeutic intervention conducted in the course of this study. The interventional procedure (described above) is standard of care. The only difference in standard of care is that the blood coagulation test is run in duplicate.

Diagnostic Test: GEM Hemochron 100 ACT

Interventions

GEM Hemochron 100 ACT DIAGNOSTIC_TEST

Activated Clotting Time

Blood coagulation test 1; Blood coagulation test 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population to be studied consists of subjects who require parenteral anticoagulant therapy with UFH in accordance with the approved label indications for heparin administration. • Therapeutic Group (T): Patients pre-heparin Patients undergoing procedure requiring anticoagulation with UFH

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.

Sponsors & Collaborators

• Accriva Diagnostics: lead

Study Sites (9)

Accriva Study Site

Los Angeles, California, 90033, United States

Location

Accriva Study Site

Sacramento, California, 95816, United States

Location

Accriva Study Site

Aurora, Colorado, 80045, United States

Location

Accriva Study Site

Baltimore, Maryland, 21215, United States

Location

Accriva Study Site

Takoma Park, Maryland, 20912, United States

Location

Accriva Study Site

New Brunswick, New Jersey, 08903, United States

Location

Accriva Study Site

Chapel Hill, North Carolina, 27514, United States

Location

Accriva Study Site

Falls Church, Virginia, 22042, United States

Location

Accriva Study Site

Charleston, West Virginia, 25304, United States

Location

Study Officials

• Marc Rubinstein, MD

  Accriva Diagnostics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 8, 2017
• Study Start: June 8, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 26, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)