Clinical trial NCT03074266: Clinical Performance of the Investigational GEM Hemochron® 100 in Populations Ages 18 Years and Older
Official title: Clinical Performance of the Investigational GEM Hemochron® 100 in Populations Ages 18 Years and Older
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Coagulation Test
Lead sponsor: Accriva Diagnostics
Sponsor class: INDUSTRY
First posted: 2017-03-08
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Detailed 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.

Eligibility criteria: 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 with UFH.
* Patients requiring heparin anticoagulant therapy for any approved indication and being managed and monitored with the ACT test.

Exclusion Criteria:

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.

Primary outcomes:
measure: 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
timeFrame: Therapeutic: 1 day; Normal: 1 day (duration of a single venous blood collection)
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Accriva Study Site
state: California
city: Sacramento
country: United States
facility: Accriva Study Site
state: California
city: Aurora
country: United States
facility: Accriva Study Site
state: Colorado
city: Baltimore
country: United States
facility: Accriva Study Site
state: Maryland
city: Takoma Park
country: United States
facility: Accriva Study Site
state: Maryland
city: New Brunswick
country: United States
facility: Accriva Study Site
state: New Jersey
city: Chapel Hill
country: United States
facility: Accriva Study Site
state: North Carolina
city: Falls Church
country: United States
facility: Accriva Study Site
state: Virginia
city: Charleston
country: United States
facility: Accriva Study Site
state: West Virginia
Study officials:
affiliation: Accriva Diagnostics
name: Marc Rubinstein, MD
role: STUDY_DIRECTOR
References: