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

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.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Diagnostic test: TEG 6s Citrated K, KH, RTH, FFH Cartridge; Diagnostic test: Clauss Fibrinogen

• Study Type: Observational
• Enrollment (Actual): 338

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California - San Francisco
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Lifebridge Health (Sinai Hospital)
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Texas
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center - San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who are at an increased risk of intervention-induced coagulopathy or at increased risk of developing intervention-induced coagulopathy complications.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Liver Transplant	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.
CV Surgery	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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 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 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 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 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.

Collaborators and Investigators

• Sponsor: Haemonetics Corporation
• Collaborators: ClinStatDevice; Boston Healthcare Technologies Consultants, LLC
• Investigators: Study Director: Jan Hartmann, MD, Haemonetics Corporation

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2021
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anticoagulants; Chelating Agents; Sequestering Agents; Calcium Chelating Agents; Citric Acid; Sodium Citrate
• Other Study ID Numbers: TP-CLN-100503

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes