Healthy
Conditions
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.
Interventions
DIAGNOSTIC_TESTTEG 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_TESTClauss 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.
Sponsors
Machaon Diagnostics
ClinStatDevice
Haemonetics Corporation
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CK-MA TEG Parameter | Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm. | Citrated Kaolin Maximum Amplitude Thromboelastographic Result |
| CK-R TEG Parameter | Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was minutes. | Citrated Kaolin Reaction Time Thromboelastographic Result |
| CKH-MA TEG Parameter | Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm. | Citrated Kaolin with Heparinase Maximum Amplitude Thromboelastographic Result |
| CKH-R TEG Parameter | Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was minutes. | Citrated Kaolin with Heparinase Reaction Time Thromboelastographic Result |
| CKH-LY30 TEG Parameter | Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was percentage. | Citrated Kaolin with Heparinase Lysis Thromboelastographic Result |
| CRTH-MA TEG Parameter | Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm. | Citrated Rapid TEG with Heparinase Maximum Amplitude Thromboelastographic Result |
| CFFH-MA TEG Parameter | Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm. | Citrated Rapid TEG with Heparinase Maximum Amplitude Thromboelastographic Result |
Countries
United States
Outcome results
None listed