Thrombocytopenia Clinical Trial
Official title:
Experimental Protocol for the Infusion of Platelets,Cryopreserved With Dimethyl Sulphoxide (DMSO) and Obtained From Multiple Donors Buffy Coats, in Patients With Severe Thrombocytopenia
The increasing need for blood components and the increasingly careful donor selection
procedures, make the availability of blood components very reduced, in particular for
platelets that are currently administered preferably "fresh" or cryopreserved, only in
emergency conditions.
Exceeding this limit through the spread of use of cryopreserved platelets in the common
clinical practice, might help clinicians to avoid wasting valuable products and face periods
of particular shortage of donors Some studies already published in the literature over the
last decade (1,2) have demonstrated the safety and efficacy of autologous cryopreserved
platelets .
The main objective of the proposed study is to evaluate the efficacy and safety of platelets,
cryopreserved with DMSO using a a new method, in patients with severe thrombocytopenia.
This is the in vivo phase of a study where availability and efficacy of cryopreserved
platelets has been assessed in vitro.
The primary objective of the study is to evaluate the hemostatic efficacy and safety in the
recipients of platelets obtained from buffy coat of multiple donors (five), cryopreserved
with DMSO using a new patented method, up to 9 months from the collection.
Further goals are the registration of any related- adverse event (idiosyncrasy, allergy,
toxicity)
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