NCT06352125

An Observational Trial to Assess the Performance of the TEG® 6s Diagnostic System With the Citrated K, KH, RTH, FFH Cartridge

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 338 (actual)
• Sponsor: Haemonetics Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is designed to assess the agreement of the TEG® 6s system using the Citrated K, KH, RTH, FFH, cartridge (hereafter referred to as the Heparin Neutralization (HN) Cartridge) with its comparators.

Conditions

• Surgery

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	TEG 6s Citrated K, KH, RTH, 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_TEST	Clauss Fibrinogen	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.

Timeline

• Start date: 2021-12-09
• Primary completion: 2023-01-31
• Completion: 2023-01-31
• First posted: 2024-04-08
• Last updated: 2024-04-08

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study