Thrombocytopenia | Protocol for the Infusion of Buffy Coat-derived Cryopreserved Platelets in Patients With Severe Thrombocytopenia
Thrombocytopenia research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: Cryopreserved buffy coat pooled platelets will be infused, after being thawed, in inpatients at U.O. of Hematology -Policlinic \"P. Giaccone\"-Palermo, falling into one of the following categories: - Stable clinical conditions and no complications with platelets ≤ 10,000/microliter; - With active bleeding and ≤ 20,000 platelets/microliter; - In the presence of: high blood pressure, high fever, rapid drop in platelets, infection, chemotherapy, coagulation abnormalities with ≤ 20,000 platelets/microliter. Exclusion Criteria: Patients - Suffering from congenital immunodeficiency - Allogeneic bone marrow transplant candidates - Bone Marrow Donors for transplantation - Undergoing bone marrow transplant or - Suffering from Hodgkin's disease and treated with purine analogues (Fludarabine, cladribine)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Thrombocytopenia Chemotherapy Induced
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Biological:Transfusion of Pooled Platelets Cryopreserved In DMSOPatients 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
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Patients with severe thrombocytopeniaIntervention 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
Start Date: July 2015
Completed Date: June 2016
Phase: Phase 4
Primary Outcome: Efficacy of infused cryopreserved platelets (changes in platelets count will be determined at 1 hour and 24 hours post-transfusion)
Secondary Outcome: Safety of cryopreserved platelets
Study sponsors, principal investigator, and references
Principal Investigator: Sergio Siragusa, MD
Lead Sponsor: Napolitano Mariasanta
Collaborator: Regione Sicilia
Wautier JL. Safety and usefulness of autologous cryopreserved platelets. Lancet. 2002 Dec 14;360(9349):1985.