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

Healthy Clinical Trial

Official title:

Procedure to Define a Normal Reference Range Using the TEG® 6s Diagnostic System With the Heparin Neutralization Cartridge in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06261580
• Other study ID #: TP-CLN-100502
• Status: Completed
• Start date: July 28, 2021
• Est. completion date: October 25, 2021

Study information

• Verified date: February 2024
• Source: Haemonetics Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: October 25, 2021
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Diagnostic Test:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Cardiovascular Research Institute - Loyola University Chicago Health Sciences	Maywood	Illinois
United States	Louisiana Coagulation / Machaon Division	New Orleans	Louisiana
United States	Machaon Diagnostics	Oakland	California

Sponsors (3)

Lead Sponsor	Collaborator
Haemonetics Corporation	ClinStatDevice, Machaon Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CK-MA TEG Parameter	Citrated Kaolin Maximum Amplitude Thromboelastographic Result	Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm.
Primary	CK-R TEG Parameter	Citrated Kaolin Reaction Time Thromboelastographic Result	Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was minutes.
Primary	CKH-MA TEG Parameter	Citrated Kaolin with Heparinase Maximum Amplitude Thromboelastographic Result	Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm.
Primary	CKH-R TEG Parameter	Citrated Kaolin with Heparinase Reaction Time Thromboelastographic Result	Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was minutes.
Primary	CKH-LY30 TEG Parameter	Citrated Kaolin with Heparinase Lysis Thromboelastographic Result	Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was percentage.
Primary	CRTH-MA TEG Parameter	Citrated Rapid TEG with Heparinase Maximum Amplitude Thromboelastographic Result	Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm.
Primary	CFFH-MA TEG Parameter	Citrated Rapid TEG with Heparinase Maximum Amplitude Thromboelastographic Result	Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm.