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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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Purpose of this study is to compare the reversal responses of 4°C cold stored platelets (CSP) versus 7 day, 22°C room temperature stored platelets (RTP) when given to healthy adult subjects who have received a loading dose of aspirin antiplatelet therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 | Active Comparator | Each research subject will participate in two study periods that will crossover from one storage product to the other storage product (Cold Stored Platelets vs Room Temperature Platelets) based on the randomization assignment. In Period 1 subjects will undergo an apheresis platelet collection, aspirin dosing, transfusion of their autologous platelets, and followed by platelet response testing and safety assessments. This is repeated in Period 2 using the other storage product. CSP is the the experimental comparator and RTP is the active comparator. |
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| Period 2 | Experimental | Each research subject will participate in two study periods that will crossover from one storage product to the other storage product (Cold Stored Platelets vs Room Temperature Platelets) based on the randomization assignment. In Period 1 subjects will undergo an apheresis platelet collection, aspirin dosing, transfusion of their autologous platelets, and followed by platelet response testing and safety assessments. This is repeated in Period 2 using the other storage product. CSP is the the experimental comparator and RTP is the active comparator. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Room Temperature stored Platelet transfusion | Biological | An autologous transfusion of platelets stored at 22°C for 7 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Glycoprotein IIb/IIIa activation at 1hr post transfusion | The primary endpoint is αIIbβ3 (GPIIb-IIIa) integrin activation determined by ARU (Verify Now Aspirin [ARUTest]) at 1h post autologous transfusion | 1 hour after autologous transfusion |
| Measure | Description | Time Frame |
|---|---|---|
| Glycoprotein IIb/IIIa activation at 4hr post transfusion | A secondary endpoint is αIIbβ3 (GPIIb-IIIa) integrin activation determined by ARU (Verify Now Aspirin [ARUTest]) at 4h post autologous transfusion | 4 hours after autologous transfusion |
| Glycoprotein IIb/IIIa activation at 24hr post transfusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moritz Stolla, MD, PhD | Bloodworks | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bloodworks Northwest Research Institute | Seattle | Washington | 98102 | United States |
Your data or specimens collected as part of this research will not be used for future research studies or given to anyone else for future research studies, even if all information that personally identifies you is removed.
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| Autologous Cold Stored Platelet transfusion | Biological | An autologous transfusion of platelets stored at 4°C for 7, 14, 21, or 28 days. |
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A secondary endpoint is αIIbβ3 (GPIIb-IIIa) integrin activation determined by ARU (Verify Now Aspirin [ARUTest]) at 24h post autologous transfusion |
| 24 hours after autologous transfusion |