Surgery
Conditions
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.
Interventions
DIAGNOSTIC_TESTTEG 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_TESTClauss 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.
Sponsors
ClinStatDevice
Boston Healthcare Technologies Consultants, LLC
Haemonetics Corporation
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Method Comparison | Outcome measure from the single blood draw was assessed within 2 hours of blood draw. | CK-MA TEG Parameter. Unit of measurement was mm. |
Countries
United States
Outcome results
None listed