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

Completed

• Conditions: Healthy
• Interventions: Diagnostic Test: TEG 6s Citrated K, KH, RTH, and FFH Cartridge; Diagnostic Test: Clauss Fibrinogen

• Registration Number: NCT06261580
• Lead Sponsor: Haemonetics Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-28
• Primary Completion: 2021-10-25
• Study Completion: 2021-10-25
• Study First Submitted: 2023-03-31
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-07
• Last Update Submitted: 2024-02-07
• Study First Posted: 2024-02-15
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	TEG 6s Citrated K, KH, RTH, and FFH Cartridge	Adult volunteers (18 years of age and older) who self-identify as being in general good health.
Healthy Volunteers	Clauss Fibrinogen	Adult volunteers (18 years of age and older) who self-identify as being in general good health.

Primary Outcome Measures

Name	Time	Method
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-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
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
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
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
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
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

Trial Locations

Locations (3)

Louisiana Coagulation / Machaon Division; 🇺🇸 New Orleans, Louisiana, United States

Machaon Diagnostics; 🇺🇸 Oakland, California, United States

Cardiovascular Research Institute - Loyola University Chicago Health Sciences; 🇺🇸 Maywood, Illinois, United States