No coin nor oath required. For personal study only.
The storage of Single Donor Platelets (SDP) for 8 days with retention of in vivo function would permit a significant improvement in blood component utilization patterns and a likely decrease in SDP outdating. Methods: A paired randomized study of normal volunteer subjects (n=10) at each of two sites was performed. In vitro data, as well as dual autologous radiolabeled recovery and survival data were collected. SDPs were collected per standard manufacturer protocols on a Haemonetics MCS+ LN9000 device using a standard disposable set. Yields and volumes were targeted across the limits of the storage bag. SDP were stored at 20--24C for 8 days with agitation. Per unit SDP values ranged from 2.4--5.2 โข 10E11 platelets, in a volume of 162--437 mL. In vitro assays (see Table ) were collected on Day 0, 5 and 8. On Day 8, the autologous SDP donor returned and had 60 mL of whole blood collected, PRP prepared and the fresh platelets labeled with either 111-In or 51-Cr using a newly established BEST Committee protocol for fresh platelet labeling. A sample of that autologous donor's Day 8 SDP was then labeled with the other isotope and both samples infused sequentially. Seven samples were collected between 2h and 10 days, post infusion. Levels of radioactivity were analyzed with a COST program. Results: See Table 1. There were no statistically significant differences between the two labeling groups at either site with regard to in vitro assays over the 8 days of storage (p>0.05, NS). Conclusion: SDP collected on the Haemonetics MCS+ LN9000 and stored for 8 days showed acceptable in vitro storage characteristics. The SDP also met FDA requirements for mean in vivo recovery and survivals in that both values were >66% of fresh-PRP whole blood derived platelets collected from the same autologous donor. This is the first clinical study seeking FDA product licensure to evaluate extended 8-Day storage of SDP using the new BEST Committee fresh whole-blood derived radiolabeled platelet protocol that uses each donor as their own control. With an approved bacterial release test, these Day 8 SDPs should be safe and effective for clinical use.
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we performed two consecutive, prospective trials studying corticosteroids and cyclosporine (CSA) as adjuncts to plasma exchange (PE). Methods: Concurrent Corticosteroids and PE: Prednisone (1 mg/kg/d) was given concurrent with PE and continued until remission was achieved. Remission was defined as a