Primary Thrombocytopenia,Unspecified, Thrombocytopenia, Thrombocytopenia Chemotherapy Induced
Conditions
Keywords
Cryopreserved platelets, thrombocytopenia, DMSO
Brief 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)
Interventions
BIOLOGICALTransfusion 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
Sponsors
Regione Sicilia
Napolitano Mariasanta
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of infused cryopreserved platelets (changes in platelets count will be determined at 1 hour and 24 hours post-transfusion) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of cryopreserved platelets | During transfusion and within 48 hours after transfusion | Any transfusion-related side effect (i.e. idiosyncrasy, allergy, toxicity) will be monitored |
Countries
Italy
Outcome results
None listed