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

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Thrombocytopenia, Primary Thrombocytopenia,Unspecified, Thrombocytopenia Chemotherapy Induced

Intervention / Treatment
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* Biological: Transfusion of Pooled Platelets Cryopreserved In DMSO


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with severe thrombocytopenia<br>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<br>* 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<br>* Other names: Buffy Coat Pooled Platelets Cryopreserved In DMSO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of infused cryopreserved platelets (changes in platelets count will be determined at 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 | 1 Hour and 24 hours post-transfusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of cryopreserved platelets | Any transfusion-related side effect (i.e. idiosyncrasy, allergy, toxicity) will be monitored | During transfusion and within 48 hours after transfusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cryopreserved platelets, thrombocytopenia, DMSO