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| Name | Class |
|---|---|
| Quintiles, Inc. | INDUSTRY |
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The study will assess the distribution and variability of whole blood clotting time (WBCT) measurement in human blood collected from healthy volunteers that is untreated and spiked with predetermined concentrations of edoxaban or enoxaparin.
Twelve healthy volunteers aged 18 to 65 years (6 subjects per spiking anticoagulant) will be enrolled. A total of 8 blood samples (12 mL/sample) will be collected by direct venipuncture. The samples from will be spiked with predetermined concentrations of edoxaban or enoxaparin (baseline, saline control and 6 specified concentrations of anticoagulant).
Each blood sample will be tested for whole blood clotting time (WBCT), Point of Care activated partial thromboplastin time (aPTT) and prothrombin time (PT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood Sample | Blood will be sampled by direct venipuncture on 8 occasions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood drawn by direct venipuncture | Other | Subjects will have blood sampled (12 mL/sample) a total of 8 times by direct venipuncture. Samples will be spiked with predetermined concentrations of anticoagulants, or saline sham. |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution and variability of WBCT measurements | Assessment of the analytical measurement range, reproducibility and precision of WBCT measurement in human blood spiked with predetermined concentrations of enoxparin and edoxaban | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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healthy volunteers
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| Name | Affiliation | Role |
|---|---|---|
| Scott Rasmussen, MD | Quintiles Phase 1 Services, LLC Overland Park KS | Principal Investigator |
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| edoxaban | Drug |
|
| Enoxaparin | Drug |
|
| Saline sham | Drug |
|
| ID | Term |
|---|---|
| C552171 | edoxaban |
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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