Effective RDP Leukoreduction

[mcharapata]

We are currently using Pall's single random donor platelet filter (Purecell PL) to provide leukoreduced platelet product to pediatric patients. We monitor the effecitveness by measuring 4 selected units each month checking for leukoreduction, platelet recovery, and platelet yield. Since December 2009, we started to see some failures with leukoreduction. We have performed a number of studies associated with investigation resulting in approximately 60 units tested within the past month, and are still experiencing about a 7% failure rate (our acceptance criteria is no greater than 5% failure rate). We have also been sending used filters to Pall for investigation (on failures), but their response time is slow (approximately 1 month). There does not appear to be anything lot specific, process specific, or technique dependent. Because we are having difficulty getting our process under control, we are exploring other ways to provide leukoreduced products to pediatric patients. Here is a list of things we are considering:

1) Discontinue the acceptance of leukoreduced single random platelet orders, but allow orders for leukoreduced 2-unit pools (filtering using Pall's Purecell LRF)

Advantages: Leukoreduced pooling process is in control. Therefore product is effectively leukoreduced.

Disadvantage: Increased donor exposure to the patient.

2) Discontinue use of Purecell PL filter and begin using Purecell LRF filter to leukoreduce single RDP's.

Advantages: The product is effectively leukoreduced (according to previous studies)

Disadvantage: The platelet yield and recovery is significantly lower. Additional orders may be necessary to effectively treat the patient.

3) Setup aliquot system for single donor leukoreduced apheresis platelets.

Advantages: The product is effectively leukoreduced (according to previous studies)

Disadvantage: Apheresis platelet inventory is highly variable. No validated system to provide this product. Apheresis storage bags have storage specifications that when a certain amount has been removed, the remaining product can no longer be stored (according to manufacturer specificaitons) resulting in increased wasted product. Developing, validating and implementation of a process is a long-term project.

We are considering (in the short-term) going with either option 1 or option 2. Ultimately, we are moving toward option 3, but this will be long-term.

The reason for my post is that I am interested in what other facilties do to provide leukoreduced platelets to pediatric patients. Any other comments regarding our situation is also welcome.

Thanks much!

Mike

[adiescast]

We aliquot from the pheresis bag. We do it on demand because the bags we aliquot into are not platelet bags (don't breathe) and we give it a 4 hour outdate.

I had not heard of the problem you mentioned about not being able to store a lesser amount of platelets in the bag. I would think that only had to do with the original collection amount rather than with a post donation reduction of the amount? Removing some of the volume should not make a difference if all constituents are removed evenly.

We do still end up with increased wastage of the product because we rarely have enough small volume transfusions to use up a pheresis platelet.

[heathervaught]

We are a blood center who does not manufacture whole-blood derived platelets for our customers (and we collect over 130,000 units of whole blood per year). Any hospital who requires a platelet transfusion for a pediatric patient prepares an aliquot from an apheresis platelet product.

One advantage to our system is that we label each apheresis platelet product with the actual yield (i.e. 3.4E11) and volume, so the facility can determine how to most effectively aliquot each product that is on their shelf. As adiescast indicated, you remove an aliquot from the original bag and use the aliquot quickly. You have to make sure that you stay within the specifications of the original bag, though. For example, we collect platelets using the Caridian (formerly Gambro) Trima device, and the original bag must contain at least 100 mL. Once you have less than 100 mL in that bag, the product must be used within 24 hours.

[adiescast]

I guess those of us in Transfusion Services are at a bit of a disadvantage on the bag requirements. Are those listed in a package insert for the set or are they on the bag label (which is covered by the time we get it...)?

Thanks!

[heathervaught]

It is in the IFU (Instructions for Use) for the bag. Your supplier should be able to share the requirements with you.

[manojpm]

Why dont you try using the ImmmugardIII filters from Terumo Corporation, if available. They are said to be more biocompatible and the recovery is also better. We have been dealing with these filters for last 5 years and not a single failure on filteration has been reported.