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

CompletedOBSERVATIONAL
Enrollment

338

Participants

Timeline

Start Date

December 9, 2021

Primary Completion Date

January 31, 2023

Study Completion Date

January 31, 2023

Conditions
Surgery
Interventions
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."

Trial Locations (7)

15213

University of Pittsburgh Medical Center, Pittsburgh

21215

Lifebridge Health (Sinai Hospital), Baltimore

70121

Ochsner Clinic, New Orleans

78229

University of Texas Health Science Center - San Antonio, San Antonio

80045

University of Colorado, Aurora

94143

University of California - San Francisco, San Francisco

02114

Massachusetts General Hospital, Boston

Sponsors
All Listed Sponsors
collaborator

ClinStatDevice

UNKNOWN

collaborator

Boston Healthcare Technologies Consultants, LLC

UNKNOWN

lead

Haemonetics Corporation

INDUSTRY