Completed
OBSERVATIONAL
NCT06352125
An Observational Trial to Assess the Performance of the TEGĀ® 6s Diagnostic System With the Citrated K, KH, RTH, FFH Cartridge
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
This clinical trial is designed to assess the agreement of the TEGĀ® 6s system using the Citrated K, KH, RTH, FFH, cartridge (hereafter referred to as the Heparin Neutralization (HN) Cartridge) with its comparators.
Interventions
Name:
TEG 6s Citrated K, KH, RTH, FFH Cartridge
Type:
DIAGNOSTIC_TEST
Description:
The TEGĀ® 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.
Name:
Clauss Fibrinogen
Type:
DIAGNOSTIC_TEST
Description:
Diagnostic Test: 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.
Primary Outcomes
Measure:
Primary Method Comparison
TimeFrame:
Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Description:
CK-MA TEG Parameter. Unit of measurement was mm.
Measure:
Primary Method Comparison
TimeFrame:
Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Description:
CKH-MA TEG Parameter. Unit of measurement was mm.
Measure:
Primary Method Comparison
TimeFrame:
Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Description:
CRTH-MA TEG Parameter. Unit of measurement was mm.
Measure:
Primary Method Comparison
TimeFrame:
Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Description:
CFFH-MA TEG Parameter. Unit of measurement was mm.
Measure:
Primary Method Comparison
TimeFrame:
Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Description:
CK-R TEG Parameter. Unit of measurement was minutes.
Measure:
Primary Method Comparison
TimeFrame:
Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Description:
CKH-R TEG Parameter. Unit of measurement was minutes.
Measure:
Primary Method Comparison
TimeFrame:
Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Description:
CKH-LY30 TEG Parameter. Unit of measurement was percentage.
Trial Information
NCT ID
NCT06352125
Status
Completed
Study Type
OBSERVATIONAL
Sponsor
Haemonetics Corporation
Last Updated
December 15, 2025