NCT02032134

Protocol for the Infusion of Buffy Coat-derived Cryopreserved Platelets in Patients With Severe Thrombocytopenia

Experimental Protocol for the Infusion of Platelets,Cryopreserved With Dimethyl Sulphoxide (DMSO) and Obtained From Multiple Donors Buffy Coats, in Patients With Severe Thrombocytopenia

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Napolitano Mariasanta · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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)

Conditions

• Thrombocytopenia
• Primary Thrombocytopenia,Unspecified
• Thrombocytopenia Chemotherapy Induced

Interventions

Type	Name	Description
BIOLOGICAL	Transfusion of Pooled Platelets Cryopreserved In DMSO	Patients with severe thrombocytopenia will be admitted as in patients at the Hematology Unit of the Policlinic "P. Giaccone"- Palermo, if they require platelet transfusion (for bleeding, in preparation for surgery, after chemotherapy); they will receive buffy coat derived cryopreserved platelets,after thawing

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2014-01-09
• Last updated: 2017-10-18

Locations

1 site across 1 country: Italy