Protocol for the Infusion of Buffy Coat-derived Cryopreserved Platelets in Patients With Severe Thrombocytopenia (MICE)
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.
|Thrombocytopenia Primary Thrombocytopenia,Unspecified Thrombocytopenia Chemotherapy Induced||Biological: Transfusion of Pooled Platelets Cryopreserved In DMSO||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Efficacy of infused cryopreserved platelets (changes in platelets count will be determined at 1 hour and 24 hours post-transfusion) [ Time Frame: 1 Hour and 24 hours post-transfusion ]To evaluate the availability of cryopreserved platelets after transfusion, the correct count (the number of platelets poured and the body surface, BMI, recipient) of platelets will be determined at 1 hour and 24 hours post transfusion, respectively
- Safety of cryopreserved platelets [ Time Frame: During transfusion and within 48 hours after transfusion ]Any transfusion-related side effect (i.e. idiosyncrasy, allergy, toxicity) will be monitored
|Study Start Date:||July 2015|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Patients with severe thrombocytopenia
Intervention Patients with severe thrombocytopenia with an active bleeding, in preparation for surgery, or after chemotherapy (prophylaxis of bleeding),will receive transfusion of Pooled Platelets Cryopreserved In DMSO With a New System
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
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT02032134
|Contact: Sergio Siragusa, MDemail@example.com|
|Contact: Cristina Riggiofirstname.lastname@example.org|
|AOUP "P.Giaccone"-Hematology Unit||Recruiting|
|Palermo, Regione Sicilia, Italy, 90127|
|Sub-Investigator: Giorgia Saccullo, MD|
|Study Director:||Sergio Siragusa, MD||Hematology Unit- University of Palermo|
|Principal Investigator:||Mariasanta Napolitano, MD||Hematology Unit- University of Palermo|