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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06352125
Other study ID # TP-CLN-100503
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 9, 2021
Est. completion date January 31, 2023

Study information

Verified date February 2023
Source Haemonetics Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 338
Est. completion date January 31, 2023
Est. primary completion date January 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
TEG 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.
Clauss 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.

Locations

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

Sponsors (3)

Lead Sponsor Collaborator
Haemonetics Corporation Boston Healthcare Technologies Consultants, LLC, ClinStatDevice

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary Method Comparison CK-MA TEG Parameter. Unit of measurement was mm. Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Primary Primary Method Comparison CKH-MA TEG Parameter. Unit of measurement was mm. Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Primary Primary Method Comparison CRTH-MA TEG Parameter. Unit of measurement was mm. Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Primary Primary Method Comparison CFFH-MA TEG Parameter. Unit of measurement was mm. Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Primary Primary Method Comparison CK-R TEG Parameter. Unit of measurement was minutes. Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Primary Primary Method Comparison CKH-R TEG Parameter. Unit of measurement was minutes. Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Primary Primary Method Comparison CKH-LY30 TEG Parameter. Unit of measurement was percentage. Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
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