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

NCT ID: NCT06261580

Last Updated: 2024-02-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 181 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-28
• Study Completion Date: 2021-10-25

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy Volunteers

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

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

Intervention Type: 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.

Clauss Fibrinogen

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Machaon Diagnostics

INDUSTRY

Sponsor Role: collaborator

ClinStatDevice

UNKNOWN

Sponsor Role: collaborator

Haemonetics Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yamini Bynagari, PhD

Role: PRINCIPAL_INVESTIGATOR

Machaon Diagnostics

Locations

Machaon Diagnostics

Oakland, California, United States

Cardiovascular Research Institute - Loyola University Chicago Health Sciences

Maywood, Illinois, United States

Louisiana Coagulation / Machaon Division

New Orleans, Louisiana, United States

Countries

United States

Other Identifiers

TP-CLN-100502

Identifier Type: -

Identifier Source: org_study_id