[h=2] A physician has contacted our blood bank regarding solvent detergent plasma, since it is being advertised as "TRALI-risk free". Are other blood banks planning to stock and use this product?[/h]

I saw where the FDA had approved a new version of it. I hadn't heard they were making the TRALI claim. I wonder what they did to make it "risk free"?

SDP has been widely used in Europe and more recently in the UK and haemovigilance has shown no cases of TRALI associated with its use which, I suspect, is where the 'TRALI free' claim originates.

As an irrelevant aside, I don't know what product(s) you have available but when we started using it we needed to amend our Transfusion Department computer as the packs of SDP are labelled with just the ABO group of the contents (ie just A, B, O or AB with no Rh Positive or Negative) and the existing software wasn't up to dealing with this strangely Rhesusless entity !

"Rhesus" Young Struik! Forsooth!

In most cases, TRALI is caused by donor leucocyte antibodies reacting with alloantigens present on the patient's leucocytes, although patient alloantibodies have been involved in some rare cases. The antibodies concerned are usually HLA class I and II specific, but HNA antibodies have also caused this. I would think that the reason they are saying that SDP is thought of as "risk free" is down, almost entirely, to the dilution factor, as the palsma is pooled, rather than the sovent detergent treatment.

Wasn't there some problem with a coag factor in the old version that was marketed in the US. Maybe something about Protein C or S levels???

Also, does anyone know how the different units from one lot are handled in ISBT? Are they labeled with the same DIN but as a thousand different split products (assuming the pools are that size)?

Malcolm is, possibly not for the first time, correct - it is the dilution which negates the TRALI risk.

Coagulation factor levels are adversely affected by the solvent detergent process but we found this to be a potential rather than an actual problem as it was equally efficacious as FFP in everyday use.

Our computer software update was to create a special category for SDP, treating it as a batch product (each pack is labelled with a barcode giving the batch number, with no further differentiation for individual packs) with checks to ensure ABO compatability with the patient.

(Sorry if that doesn't seem very clear - I am still recovering from my well-deserved slapped 'Rhesus' wrists - thanks to young Mr Needs !)

The US disallowed SD Plasma because non-lipid-enveloped viruses were not inactivated by the original process.

"In solvent/detergent (SD)-treated plasma, lipid-enveloped viruses are efficiently inactivated. This method, however, does not affect non-lipid-enveloped viruses" Transfusion. 2000 Jan;40(1):84-90.

Viral safety of solvent/detergent-treated plasma.

Solheim BG, Rollag H, Svennevig JL, Arafa O, Fosse E, Bergerud U.

Source

Institute of Immunology, Rikshospitalet, The National Hospital, University of Oslo, Norway. b.g.solheim@rh.uio.no

I believe there was also a problem with excessive bleeding. In addition Aprotinin was frequently used with SD plasma which caused with Aprotinin sensitivity should a second procedure need to be done. I have (tried) to attach a nice review of the SD plasma history.

The current product Octaplas, will probably be distributed through your blood supplier. However the cost is rumored to be 3x what FFP costs.

The US disallowed SD Plasma because non-lipid-enveloped viruses were not inactivated by the original process.

"In solvent/detergent (SD)-treated plasma, lipid-enveloped viruses are efficiently inactivated. This method, however, does not affect non-lipid-enveloped viruses" Transfusion. 2000 Jan;40(1):84-90.

Viral safety of solvent/detergent-treated plasma.

Solheim BG, Rollag H, Svennevig JL, Arafa O, Fosse E, Bergerud U.

Source

Institute of Immunology, Rikshospitalet, The National Hospital, University of Oslo, Norway. b.g.solheim@rh.uio.no