Clinical trial NCT06261580: Normal Reference Range Study With the TEG6s Heparin Neutralization Cartridge in Healthy Volunteers
Official title: Procedure to Define a Normal Reference Range Using the TEG® 6s Diagnostic System With the Heparin Neutralization Cartridge in Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Haemonetics Corporation
Sponsor class: INDUSTRY
Collaborators: name: Machaon Diagnostics
name: ClinStatDevice
First posted: 2024-02-15
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Healthy Volunteers

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.


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

Primary outcomes:
measure: CK-MA TEG Parameter
timeFrame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm.
measure: CK-R TEG Parameter
timeFrame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was minutes.
measure: CKH-MA TEG Parameter
timeFrame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm.
measure: CKH-R TEG Parameter
timeFrame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was minutes.
measure: CKH-LY30 TEG Parameter
timeFrame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was percentage.
measure: CRTH-MA TEG Parameter
timeFrame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm.
measure: CFFH-MA TEG Parameter
timeFrame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm.
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Machaon Diagnostics
state: California
city: Maywood
country: United States
facility: Cardiovascular Research Institute - Loyola University Chicago Health Sciences
state: Illinois
city: New Orleans
country: United States
facility: Louisiana Coagulation / Machaon Division
state: Louisiana
Study officials:
affiliation: Machaon Diagnostics
name: Yamini Bynagari, PhD
role: PRINCIPAL_INVESTIGATOR
References: