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

Completed

• Conditions: Surgery
• Interventions: Diagnostic Test: TEG 6s Citrated K, KH, RTH, FFH Cartridge; Diagnostic Test: Clauss Fibrinogen

• Registration Number: NCT06352125
• Lead Sponsor: Haemonetics Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-09
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31
• Status Verified: 2023-02
• Study First Submitted: 2024-04-02
• Study First Submitted QC: 2024-04-02
• Last Update Submitted: 2024-04-02
• Study First Posted: 2024-04-08
• Last Update Posted: 2024-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 338

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Liver Transplant	TEG 6s Citrated K, KH, RTH, FFH Cartridge	-
CV Surgery	Clauss Fibrinogen	-
CV Surgery	TEG 6s Citrated K, KH, RTH, FFH Cartridge	-
Liver Transplant	Clauss Fibrinogen	-

Primary Outcome Measures

Name	Time	Method
Primary Method Comparison	Outcome measure from the single blood draw was assessed within 2 hours of blood draw.	CKH-LY30 TEG Parameter. Unit of measurement was percentage.

Trial Locations

Locations (7)

Ochsner Clinic; 🇺🇸 New Orleans, Louisiana, United States

Lifebridge Health (Sinai Hospital); 🇺🇸 Baltimore, Maryland, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of California - San Francisco; 🇺🇸 San Francisco, California, United States

University of Texas Health Science Center - San Antonio; 🇺🇸 San Antonio, Texas, United States