Experimental Protocol for the Infusion of Platelets,Cryopreserved With Dimethyl Sulphoxide (DMSO) and Obtained From Multiple Donors Buffy Coats, in Patients With Severe Thrombocytopenia
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Thrombocytopenia
- Sponsor
- Napolitano Mariasanta
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Efficacy of infused cryopreserved platelets (changes in platelets count will be determined at 1 hour and 24 hours post-transfusion)
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
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)
Investigators
Napolitano Mariasanta
Assistant Professor (ricercatore td)
University of Palermo
Eligibility Criteria
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
- •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)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Safety of cryopreserved platelets(During transfusion and within 48 hours after transfusion)