Normal Reference Range Study With the TEG6s Heparin Neutralization Cartridge in Healthy Volunteers

Procedure to Define a Normal Reference Range Using the TEG® 6s Diagnostic System With the Heparin Neutralization Cartridge in Healthy Volunteers

This trial holds minimal risk to the trial volunteers and consists of obtaining whole blood via venipuncture to perform coagulation parameter measurements to define a Normal Reference Range.

Written consent to participate in the study will be obtained prior to volunteer screening per site procedures.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Diagnostic test: TEG 6s Citrated K, KH, RTH, and FFH Cartridge; Diagnostic test: Clauss Fibrinogen

• Study Type: Observational
• Enrollment (Actual): 181

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94609
      • Machaon Diagnostics
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Cardiovascular Research Institute - Loyola University Chicago Health Sciences
  • Louisiana
    • New Orleans, Louisiana, United States, 70118
      • Louisiana Coagulation / Machaon Division

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult Healthy Volunteers

Description

Inclusion Criteria:

• Adult volunteers (18 years of age and older) who self-identify as being in general good health.

Exclusion Criteria:

• Volunteers with any acute illness or uncontrolled chronic disease
• Volunteers with any type of cancer
• Volunteers with diabetes
• Volunteers with renal disease
• Volunteers with liver disease
• Volunteers with morbid obesity
• Volunteers with autoimmune or inflammatory diseases
• Volunteers with known coagulation and/or bleeding disorders (e.g., hemophilia, Von Willebrand's disease)
• Volunteers currently abusing alcohol (defined as more than 3 drinks for women and more than 4 drinks for men on any given day, or 7 drinks for women and 14 drinks for men throughout the week) or taking illicit drugs
• Volunteers with hereditary fibrinolytic bleeding disorders
• Volunteers with altered coagulation due to the presence of direct oral anticoagulants (e.g., apixaban, rivaroxaban, dabigatran) in the blood
• Volunteers on any fibrinolytic activators (e.g., Streptokinase, t-PA, Reteplase, Tenecteplase, Urokinase, APSAC, Staphylokinase)
• Volunteers who have had recent surgery (within the last four weeks)
• Volunteers with any injuries leading to substantial bleeding or bruising (within the last two weeks prior to blood donation)
• Volunteers with bruising, wounds, or scarring around the selected venipuncture site
• Volunteers deemed unfit for participation in the trial by the principal investigator
• Volunteers participating in another clinical trial that would not be scientifically or medically compatible with this trial
• Volunteers who have been on P2Y12 inhibitors within the last 30 days
• Volunteers receiving treatment with low molecular weight heparin (e.g., enoxaparin)
• Volunteers with altered coagulation due to the presence of drugs known to affect the coagulation status in the blood (see Table 1)
• Volunteers who have participated in this trial previously

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Healthy Volunteers; Adult volunteers (18 years of age and older) who self-identify as being in general good health.

Diagnostic test: TEG 6s Citrated K, KH, RTH, and FFH Cartridge; The TEG® 6s uses the Global Hemostasis with Heparin Neutralization (HN) Cartridge to test the hemostasis properties of citrated blood samples using four different assays/reagents simultaneously, one in each of the four cartridge channels.; Diagnostic test: Clauss Fibrinogen; Fibrinogen, also known as Factor I, is a plasma protein that can be transformed by thrombin into a fibrin gel ("the clot"). Fibrinogen is synthesized in the liver and circulates in the plasma as a disulfide-bonded dimer of 3 subunit chains. The biological half-life of plasma fibrinogen is 3 to 5 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CK-MA TEG Parameter	Citrated Kaolin Maximum Amplitude Thromboelastographic Result	Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm.
CK-R TEG Parameter	Citrated Kaolin Reaction Time Thromboelastographic Result	Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was minutes.
CKH-MA TEG Parameter	Citrated Kaolin with Heparinase Maximum Amplitude Thromboelastographic Result	Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm.
CKH-R TEG Parameter	Citrated Kaolin with Heparinase Reaction Time Thromboelastographic Result	Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was minutes.
CKH-LY30 TEG Parameter	Citrated Kaolin with Heparinase Lysis Thromboelastographic Result	Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was percentage.
CRTH-MA TEG Parameter	Citrated Rapid TEG with Heparinase Maximum Amplitude Thromboelastographic Result	Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm.
CFFH-MA TEG Parameter	Citrated Rapid TEG with Heparinase Maximum Amplitude Thromboelastographic Result	Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm.

Collaborators and Investigators

• Sponsor: Haemonetics Corporation
• Collaborators: Machaon Diagnostics; ClinStatDevice
• Investigators: Principal Investigator: Yamini Bynagari, PhD, Machaon Diagnostics

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2021
• Primary Completion (Actual): October 25, 2021
• Study Completion (Actual): October 25, 2021

Study Registration Dates

• First Submitted: March 31, 2023
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anticoagulants; Chelating Agents; Sequestering Agents; Calcium Chelating Agents; Citric Acid; Sodium Citrate
• Other Study ID Numbers: TP-CLN-100502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes