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Cold Apheresis Platelets in PAS (CAPP)
This is a platelet transfusion study. The purpose of this study is to measure the life span and quality of platelets stored in a refrigerator. Participants will give platelets by apheresis. Platelets will be stored for 3 -20 days. A small portion of the subject's own stored platelets will be tagged with a radioactive isotope and infused back into the participant. This will enable us to track how many transfused platelets survive after storage in the refrigerator.
Details
| Lead sponsor | Bloodworks |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 80 |
| Start date | 2016-04 |
| Completion | 2019-01 |
Conditions
- Platelet Transfusion
Interventions
- Apheresis platelet collection
- Refrigerated storage of apheresis platelets in PAS/plasma
- Infusion of aliquot of autologous radiolabeled platelets
- In vitro tests
Primary outcomes
- Maximal storage time with acceptable recovery and survival (as defined below) — up to 20 days storage at 4°C
Tables of recovery and survival summary statistics will display values by group from fresh and stored platelets. Recovery and survival of stored platelets as percentage of corresponding fresh platelets will be plotted against days stored. Regression methods will be used to determine if there is evidence of any trend in the mean storage or recovery of 4°C stored platelets with respect to storage time as a percentage of each subject's fresh platelet results. Histograms of recovery and survival as percentage of 4°C stored platelet measurements will be plotted, and corresponding confidence intervals will be calculated.
Countries
United States