Double red cell collection:

What is the protocol?? Is it necessary to have saline compensation during or after the procedure? Do we have to add any storage solution to the red cell units after collection?? The machine we intend to use is TRIMA accel..

Lyla_n - You should be able to contact your local CaridianBCT rep for answers to the questions you are asking. I have a sample SOP for the most recent software, version 6.0, which has a pre-attache leukoreduction filter... I'm assuming that you're using that???

I can't figure out how to attach to this, so if you post your email, I will email it to you.

To answer your questions - it is NOT necessary to have saline replacement, however I don't know anyone who doesn't do that. The donors just feel better, so why not?

Yes, you do need to use additive solution. In the US, the Trima Accel is cleared for use with AS-3, it is also available from CaridianBCT (and other places). I'm not sure if/what it is cleared for in other world areas if you're not in the US.

Lyla_n - You should be able to contact your local CaridianBCT rep for answers to the questions you are asking. I have a sample SOP for the most recent software, version 6.0, which has a pre-attache leukoreduction filter... I'm assuming that you're using that???

I can't figure out how to attach to this, so if you post your email, I will email it to you.

To answer your questions - it is NOT necessary to have saline replacement, however I don't know anyone who doesn't do that. The donors just feel better, so why not?

Yes, you do need to use additive solution. In the US, the Trima Accel is cleared for use with AS-3, it is also available from CaridianBCT (and other places). I'm not sure if/what it is cleared for in other world areas if you're not in the US.

well we did contact the local caridian bct rep and he told us that we dont need saline replacement.. can u tell me from where can i get the specifications as to what should be the volume of a double red cell product? we have configured it to 230ml of each split and saline replacement for >500ml? can u give me a ref for double red cell quality criteria.

Are you in the US?? There is a whole Draft Guidance document for automated RBCs from January 2001.

(http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm080764.pdf

Basically, the average dose needs to be 60 gm Hgb (non leukoreduced) or 180 mls of absolute RBC mass. So most blood centers in the US are targeting 200 for the RBC mass - which is a 250 mL total product volume (to ensure they are well above that 180). 230mLs seems a bit excessive... unless you're talking about the total product volume, then you may have QC issues. Trima relies on a reasonably accurate fingerstick. It is well documented that fingersticks tend to be off by 2-3 points. If your techs do not use proper techniques and you're off by more than that - you may struggle with low doses... you'll want to keep an eye on that and adjust as needed to ensure you meet all requirements.

If your using the new software/ kits to collect leukoreduced RBCs - the standards are a bit lower, and most US customers are targeting 170-180 mLs for the RBCs. (Which makes your 230 ml product volume make more sense... if that's what you're doing. 180 ml RBC mass would be about a 225 ml product volume)

Trima allows for 100% fluid balance saline replacement, again, most US centers are doing this... Trima will calculate the volume taken from the donor and replace that volume in ACDA+ Saline. It's not required by Trima, nor any regulatory agency ... but donors tend to feel better, so why not?

If the link to the Guidance document above doesn't work for you . just go to www.fda.gov and type "RBC apheresis" in the search box and it should pop up pretty quickly for you. www.aabb.org would have similar standards.

Good Luck!