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

NCT06352125 | Completed FDA Device

• 1 other identifier: TP-CLN-100503
• Study Type: observational
• Target: 338
• Locations: 1 country
• Sites: 7

Brief 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

Outcome Measures

Primary Outcomes (7)

• 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.

Study Arms (2)

Liver Transplant

Diagnostic Test: TEG 6s Citrated K, KH, RTH, FFH Cartridge; Diagnostic Test: Clauss Fibrinogen

CV Surgery

Diagnostic Test: TEG 6s Citrated K, KH, RTH, FFH Cartridge; Diagnostic Test: Clauss Fibrinogen

Interventions

TEG 6s Citrated K, KH, RTH, FFH Cartridge DIAGNOSTIC_TEST

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.

CV Surgery; Liver Transplant

Clauss Fibrinogen DIAGNOSTIC_TEST

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; Liver Transplant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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):
• 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
• 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
• Adult patients (18 years of age and older) who underwent liver transplantation (recipients)

You may not qualify if:

• Patients with hereditary chronic coagulation and/or bleeding disorders
• Patients with hereditary fibrinolytic bleeding disorders
• Patients deemed unfit for participation in the by the principal investigator
• Patients participating in another clinical that would not be scientifically or medically compatible with this trial
• Patients with currently altered coagulation due to the presence of oral anticoagulants (e.g., apixaban, rivaroxaban, dabigatran, warfarin)

Sponsors & Collaborators

• Haemonetics Corporation: lead
• ClinStatDevice: collaborator
• Boston Healthcare Technologies Consultants, LLC: collaborator

Study Sites (7)

University of California - San Francisco

San Francisco, California, 94143, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Ochsner Clinic

New Orleans, Louisiana, 70121, United States

Location

Lifebridge Health (Sinai Hospital)

Baltimore, Maryland, 21215, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas Health Science Center - San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Adelmann D, Hartmann J, Moore HB, Yockelson SR, Dageforde LA, Chitilian H, Little MB, Bliden KP, Gurbel PA, Tantry US, Subramaniam K, Sakai T. TEG (R) 6s Heparin Neutralization Cartridge for Hemostatic Assessment of Patients Undergoing Cardiovascular Surgery. Anesthesiology. 2026 Jan 1;144(1):103-115. doi: 10.1097/ALN.0000000000005759. Epub 2025 Sep 18.

  PMID: 40965969 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole Blood Samples

MeSH Terms

Interventions

Thrombelastography

Intervention Hierarchy (Ancestors)

Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Jan Hartmann, MD

  Haemonetics Corporation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: December 9, 2021
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: April 8, 2024

Record last verified: 2023-02

Locations

US (7)