"Fibrin clots" in thawed cryoprecipitate

A transfusion medicine physician who works for a large multi-state blood collection organization is aware of recent reports from hospitals about "fibrin clots" in thawed cryoprecipitate. Her facility has been manufacturing cryoprecipitate for many years, but only recently have they had these reports. Several cases have been tracked to procedural issues in the hospital following thawing the product. However, a recent case from a large hospital was notable for having large, flocculent material in the thawed products even after the product was thawed at 37C and maintained at room temp. The concentrations of fibrinogen and FVIII have been several times the minimum requirement on QC testing. The inquiring physician wonders if anyone else has seen this problem? What might be some causes? The inquiring colleague would like some ideas to begin investigating this from the manufacturing standpoint. Could temperature excursions during manufacture play a role in generating insoluble fibrin? Would very high concentrations of fibrinogen & FVIII in the cryoprecipitate product be responsible?

The Editors think that colleagues will find the discussion, "Clots in Thawed FFP", to be germane.

The following comments have been received in response.

ADDENDA Jan. 18, 2010

1. A colleague in Iowa reports that he has seen this problem with cryoprecipitate two or three times during his ~40 years as a Medical Technologist. He does not recall hearing back from their blood center regarding the cause of the flocculation.
   
   
2. A colleague in the San Diego area reports that at her large multi-facility hospital system they have recently experienced the very same observation regarding cryoprecipitate in their transfusion service laboratory. They have been using pre-pooled cryoprecipitate for over a year now and never experienced a problem until the past month or so. They finally had to extend the thaw time from 12 minutes to 20 minutes and after 5 minutes in the plasma thawing system they remove the bag and unfold it (each unit comes folded in a box) so that the entire bag is thawed evenly. This seemed to fix the problem so far.

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