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

NCT06261580 | Completed FDA Device

• 1 other identifier: TP-CLN-100502
• Study Type: observational
• Target: 181
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• 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.

Study Arms (1)

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; Diagnostic Test: Clauss Fibrinogen

Interventions

TEG 6s Citrated K, KH, RTH, and FFH Cartridge DIAGNOSTIC_TEST

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.

Healthy Volunteers

Clauss Fibrinogen DIAGNOSTIC_TEST

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.

Healthy Volunteers

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

Adult Healthy Volunteers

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haemonetics Corporation: lead
• Machaon Diagnostics: collaborator
• ClinStatDevice: collaborator

Study Sites (3)

Machaon Diagnostics

Oakland, California, 94609, United States

Location

Cardiovascular Research Institute - Loyola University Chicago Health Sciences

Maywood, Illinois, 60153, United States

Location

Louisiana Coagulation / Machaon Division

New Orleans, Louisiana, 70118, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Adult volunteers (18 years of age and older) who self-identify as being in general good health were recruited at 3 US centers. Whole Blood Samples and frozen plasma were collected for this study.

MeSH Terms

Interventions

Thrombelastography

Intervention Hierarchy (Ancestors)

Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Yamini Bynagari, PhD

  Machaon Diagnostics

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: February 15, 2024
• Study Start: July 28, 2021
• Primary Completion: October 25, 2021
• Study Completion: October 25, 2021
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)