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

Haemonetics

Status: Completed

Conditions: Surgery

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

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT06352125

TP-CLN-100503

Details and patient eligibility

About

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.

Enrollment: 338 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

338 participants in 2 patient groups

Liver Transplant

Treatment:

Diagnostic Test: Clauss Fibrinogen

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

CV Surgery

Treatment:

Diagnostic Test: Clauss Fibrinogen

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