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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06352125
• Other study ID #: TP-CLN-100503
• Status: Completed
• Start date: December 9, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2023
• Source: Haemonetics Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients who are at an increased risk of intervention-induced coagulopathy or at increased risk of developing intervention-induced coagulopathy complications undergoing cardiovascular surgeries or liver transplantation (recipients):

1. Adult patients (18 years of age and older) who underwent cardiovascular on-pump surgeries or procedures (e.g., CABG) who were at an increased risk of coagulopathy-related complications1 (see Table 9.3-1) as well as patients with clinically apparent or suspected coagulopathy or

2. Adult patients (18 years of age and older) who underwent not-on-pump cardiovascular surgeries (e.g., lead extraction) or cardiovascular procedures (e.g., minimally invasive valve or percutaneous cardiac procedures, such as PCI, LAAC, TAVR/TAVI) associated with the use of heparin who were at an increased risk of coagulopathy-related complications1 (see Table 9.3-1) as well as patients with clinically apparent or suspected coagulopathy or

3. Adult patients (18 years of age and older) who underwent liver transplantation (recipients)

Exclusion Criteria:

1. Patients with hereditary chronic coagulation and/or bleeding disorders

2. Patients with hereditary fibrinolytic bleeding disorders

3. Patients deemed unfit for participation in the by the principal investigator

4. Patients participating in another clinical that would not be scientifically or medically compatible with this trial

5. Patients with currently altered coagulation due to the presence of oral anticoagulants (e.g., apixaban, rivaroxaban, dabigatran, warfarin)

Related Conditions & MeSH terms

• Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	Lifebridge Health (Sinai Hospital)	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Ochsner Clinic	New Orleans	Louisiana
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	University of Texas Health Science Center - San Antonio	San Antonio	Texas
United States	University of California - San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
Haemonetics Corporation	Boston Healthcare Technologies Consultants, LLC, ClinStatDevice

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Method Comparison	CK-MA TEG Parameter. Unit of measurement was mm.	Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Primary	Primary Method Comparison	CKH-MA TEG Parameter. Unit of measurement was mm.	Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Primary	Primary Method Comparison	CRTH-MA TEG Parameter. Unit of measurement was mm.	Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Primary	Primary Method Comparison	CFFH-MA TEG Parameter. Unit of measurement was mm.	Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Primary	Primary Method Comparison	CK-R TEG Parameter. Unit of measurement was minutes.	Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Primary	Primary Method Comparison	CKH-R TEG Parameter. Unit of measurement was minutes.	Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Primary	Primary Method Comparison	CKH-LY30 TEG Parameter. Unit of measurement was percentage.	Outcome measure from the single blood draw was assessed within 2 hours of blood draw.