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| Name | Class |
|---|---|
| ClinStatDevice | UNKNOWN |
| Boston Healthcare Technologies Consultants, LLC | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liver Transplant |
| ||
| CV Surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEG 6s Citrated K, KH, RTH, FFH Cartridge | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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 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 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 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 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 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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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):
Exclusion Criteria:
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Patients who are at an increased risk of intervention-induced coagulopathy or at increased risk of developing intervention-induced coagulopathy complications.
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| Name | Affiliation | Role |
|---|---|---|
| Jan Hartmann, MD | Haemonetics Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California - San Francisco | San Francisco | California | 94143 | United States | ||
| University of Colorado |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40965969 | Derived | Adelmann D, Hartmann J, Moore HB, Yockelson SR, Dageforde LA, Chitilian H, Little MB, Bliden KP, Gurbel PA, Tantry US, Subramaniam K, Sakai T. TEG (R) 6s Heparin Neutralization Cartridge for Hemostatic Assessment of Patients Undergoing Cardiovascular Surgery. Anesthesiology. 2026 Jan 1;144(1):103-115. doi: 10.1097/ALN.0000000000005759. Epub 2025 Sep 18. |
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Whole Blood Samples
|
| Clauss Fibrinogen | Diagnostic Test | 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. |
|
| Aurora |
| Colorado |
| 80045 |
| United States |
| Ochsner Clinic | New Orleans | Louisiana | 70121 | United States |
| Lifebridge Health (Sinai Hospital) | Baltimore | Maryland | 21215 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Texas Health Science Center - San Antonio | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D013916 | Thrombelastography |
| ID | Term |
|---|---|
| D001780 | Blood Coagulation Tests |
| D006403 | Hematologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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