Platelet-rich plasma and blood components for non-transfusion use: technical and medicolegal aspects.

There are a large number of publications describing the use of platelet-rich plasma (PRP) in multiple fields of application. These illustrate a large number of therapeutic elements with different and specific actions within 'platelet gel' (this term is used in the current regulations to define this product). This term, however, lacks specificity and, depending on the method used in its production is variable both in its blood composition and in platelet concentration, and several publications consider better and easier methods of platelet gel production, which may or may not lead to greater standardization in the product. The authors illustrate the general aspects of PRP and other blood components for non-transfusion use, briefly touching on the history and different fields of application and the rational of for its use. Given the increased use of such preparations, the authors describe critically the regulations in force in Europe and propose a new regulatory framework aimed to simplify and facilitate the use of such material as a therapeutic agent within medicine.

The role of erythrocytapheresis in secondary erythrocytosis therapy.

In chronic respiratory insufficiency secondary erythrocytosis (SPC), causing pulmonary hypertension and dx ventricular insufficiency, is often noticed. An alternative therapy to phlebotomy for SPC is isovolemic large volume erythrocytapheresis performed with cell separator (CSE) in order to quickly remove a large volume of red blood cells (RBC) while saving plasma proteins and clotting factors. In order to evaluate the efficiency and safety of CSE in SPC we reported a retrospective analysis of our experience with 61 SPC patients: from April 1996 to May 1998 we performed 208 CSE using Haemonetics MCS3P (TAE protocol). Before every apheresis procedure we verified Hb (in median 18.8 g/dl), Ht (in median 58.4%), viscometry, coagulation test, EGA, PFR and ECG. 11 patients were treated with 1 CSE, 12 with 3, 29 with 4 and 9 with 5. The mean volume of RBC removed was 576 ml (range 426-800); Hb post CSE averaged 14.4 g/dl and Ht post CSE averaged 42.7%; hematic viscosity post CSE was significantly reduced while tissue oxygen tension increased: the improvement of symptomatology and hematochemical parameters was maintained on the average for 6.5 months. All the procedures were well tolerated and light side effects (paresthesias citrate-depending in 27 apheresis) were easily controlled. CSE, compared to phlebotomy, has the advantage of selectively removing RBC without loss of clotting factors, platelets and plasma proteins. Although CSE has relatively high costs we noticed a decrease of hospital recurrence (about 50-65%) in SPC patients treated with apheresis.