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

Completed

Conditions studied: Surgery

In brief

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.

Key facts

Study ID

NCT06352125

Run by

Haemonetics Corporation

People needed

338

Starts

2021-12-09

Expected to finish

2023-01-31

Last updated by the study team

2024-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

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

Full record on ClinicalTrials.gov

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