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| Name | Class |
|---|---|
| Machaon Diagnostics | INDUSTRY |
| ClinStatDevice | UNKNOWN |
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This trial holds minimal risk to the trial volunteers and consists of obtaining whole blood via venipuncture to perform coagulation parameter measurements to define a Normal Reference Range.
Written consent to participate in the study will be obtained prior to volunteer screening per site procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Adult volunteers (18 years of age and older) who self-identify as being in general good health. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEG 6s Citrated K, KH, RTH, and 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 |
|---|---|---|
| CK-MA TEG Parameter | Citrated Kaolin Maximum Amplitude Thromboelastographic Result | Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm. |
| CK-R TEG Parameter | Citrated Kaolin Reaction Time Thromboelastographic Result | Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was minutes. |
| CKH-MA TEG Parameter | Citrated Kaolin with Heparinase Maximum Amplitude Thromboelastographic Result | Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm. |
| CKH-R TEG Parameter | Citrated Kaolin with Heparinase Reaction Time Thromboelastographic Result | Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was minutes. |
| CKH-LY30 TEG Parameter | Citrated Kaolin with Heparinase Lysis Thromboelastographic Result | Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was percentage. |
| CRTH-MA TEG Parameter | Citrated Rapid TEG with Heparinase Maximum Amplitude Thromboelastographic Result | Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm. |
| CFFH-MA TEG Parameter |
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Inclusion Criteria:
• Adult volunteers (18 years of age and older) who self-identify as being in general good health.
Exclusion Criteria:
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Adult Healthy Volunteers
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| Name | Affiliation | Role |
|---|---|---|
| Yamini Bynagari, PhD | Machaon Diagnostics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Machaon Diagnostics | Oakland | California | 94609 | United States | ||
| Cardiovascular Research Institute - Loyola University Chicago Health Sciences |
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| ID | Term |
|---|---|
| D013916 | Thrombelastography |
| ID | Term |
|---|---|
| D001780 | Blood Coagulation Tests |
| D006403 | Hematologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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Adult volunteers (18 years of age and older) who self-identify as being in general good health were recruited at 3 US centers. Whole Blood Samples and frozen plasma were collected for this study.
|
| Clauss Fibrinogen | Diagnostic Test | 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. |
|
Citrated Rapid TEG with Heparinase Maximum Amplitude Thromboelastographic Result |
| Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm. |
| Maywood |
| Illinois |
| 60153 |
| United States |
| Louisiana Coagulation / Machaon Division | New Orleans | Louisiana | 70118 | United States |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |