NCT06261580
Normal Reference Range Study With the TEG6s Heparin Neutralization Cartridge in Healthy Volunteers
COMPLETED
NCT06261580
OBSERVATIONAL
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.
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
Healthy
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- Type: DIAGNOSTIC_TEST
- Name: TEG 6s Citrated K, KH, RTH, and FFH Cartridge
- Description: 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.
- Arm Group Labels: Healthy Volunteers
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- Type: DIAGNOSTIC_TEST
- Name: Clauss Fibrinogen
- Description: 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.
- Arm Group Labels: Healthy Volunteers
- Haemonetics Corporation