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

Haemonetics

Status: Completed

Conditions: Healthy

Treatments: Diagnostic Test: Clauss Fibrinogen; Diagnostic Test: TEG 6s Citrated K, KH, RTH, and FFH Cartridge

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT06261580

TP-CLN-100502

Details and patient eligibility

About

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.

Enrollment: 181 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

181 participants in 1 patient group

Healthy Volunteers

Description:

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

Treatment:

Diagnostic Test: TEG 6s Citrated K, KH, RTH, and FFH Cartridge

Diagnostic Test: Clauss Fibrinogen