NCT06261580

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 181 (actual)
• Sponsor: Haemonetics Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
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.
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: 2021-07-28
• Primary completion: 2021-10-25
• Completion: 2021-10-25
• First posted: 2024-02-15
• Last updated: 2024-02-15

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study