Clinical trial NCT06352125: An Observational Trial to Assess the Performance of the TEG® 6s Diagnostic System With the Citrated K, KH, RTH, FFH Cartridge
Official title: An Observational Trial to Assess the Performance of the TEG® 6s Diagnostic System With the Citrated K, KH, RTH, FFH Cartridge
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Lead sponsor: Haemonetics Corporation
Sponsor class: INDUSTRY
Collaborators: name: ClinStatDevice
name: Boston Healthcare Technologies Consultants, LLC
First posted: 2024-04-08
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Primary Method Comparison
timeFrame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
measure: Primary Method Comparison
timeFrame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
measure: Primary Method Comparison
timeFrame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
measure: Primary Method Comparison
timeFrame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
measure: Primary Method Comparison
timeFrame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
measure: Primary Method Comparison
timeFrame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
measure: Primary Method Comparison
timeFrame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California - San Francisco
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: New Orleans
country: United States
facility: Ochsner Clinic
state: Louisiana
city: Baltimore
country: United States
facility: Lifebridge Health (Sinai Hospital)
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: San Antonio
country: United States
facility: University of Texas Health Science Center - San Antonio
state: Texas
Study officials:
affiliation: Haemonetics Corporation
name: Jan Hartmann, MD
role: STUDY_DIRECTOR
References: