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Completed

NCT Number: NCT06352125

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.

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Key information

Conditions

Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California - San Francisco, San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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):

  • 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)

Exclusion criteria

  • 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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Primary Method Comparison

    Time frame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.

    CK-MA TEG Parameter. Unit of measurement was mm.

  2. Primary Method Comparison

    Time frame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.

    CKH-MA TEG Parameter. Unit of measurement was mm.

  3. Primary Method Comparison

    Time frame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.

    CRTH-MA TEG Parameter. Unit of measurement was mm.

  4. Primary Method Comparison

    Time frame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.

    CFFH-MA TEG Parameter. Unit of measurement was mm.

  5. Primary Method Comparison

    Time frame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.

    CK-R TEG Parameter. Unit of measurement was minutes.

  6. Primary Method Comparison

    Time frame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.

    CKH-R TEG Parameter. Unit of measurement was minutes.

  7. Primary Method Comparison

    Time frame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.

    CKH-LY30 TEG Parameter. Unit of measurement was percentage.

Sponsors and collaborators

Lead sponsor

Haemonetics Corporation

Industry

Collaborators

  • Boston Healthcare Technologies Consultants, LLC
  • ClinStatDevice

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 8, 2024
Registry last updated
Apr 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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