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

Napolitano Mariasanta

Status and phase: Terminated; Phase 4

Conditions: Thrombocytopenia; Thrombocytopenia Chemotherapy Induced; Primary Thrombocytopenia,Unspecified

Treatments: Biological: Transfusion of Pooled Platelets Cryopreserved In DMSO

Study type: Interventional

Funder types: Other

Identifiers

NCT02032134

CUP: G33F1100003000

Details and patient eligibility

About

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.

Full 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)

Enrollment: 5 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Patients with severe thrombocytopenia

Other group

Description:

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

Treatment:

Biological: Transfusion of Pooled Platelets Cryopreserved In DMSO