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

This study has been terminated.
(recruitment failure within the interval of available CRY BC-PLTs for the study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02032134
First Posted: January 9, 2014
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Regione Sicilia
Information provided by (Responsible Party):
Napolitano Mariasanta, University of Palermo
  Purpose

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.


Condition Intervention Phase
Thrombocytopenia Primary Thrombocytopenia,Unspecified Thrombocytopenia Chemotherapy Induced Biological: Transfusion of Pooled Platelets Cryopreserved In DMSO Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Experimental Protocol for the Infusion of Platelets,Cryopreserved With Dimethyl Sulphoxide (DMSO) and Obtained From Multiple Donors Buffy Coats, in Patients With Severe Thrombocytopenia

Resource links provided by NLM:


Further study details as provided by Napolitano Mariasanta, University of Palermo:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Safety of cryopreserved platelets [ Time Frame: During transfusion and within 48 hours after transfusion ]
    Any transfusion-related side effect (i.e. idiosyncrasy, allergy, toxicity) will be monitored


Enrollment: 5
Study Start Date: July 2015
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Patients with severe thrombocytopenia
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
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
Other Names:
  • New Cryopreservation kit (Promedical ®)
  • Buffy Coat Pooled Platelets Cryopreserved In DMSO

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)

  Eligibility

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032134


Locations
Italy
AOUP "P.Giaccone"-Hematology Unit
Palermo, Regione Sicilia, Italy, 90127
Sponsors and Collaborators
Napolitano Mariasanta
Regione Sicilia
Investigators
Study Director: Sergio Siragusa, MD Hematology Unit- University of Palermo
Principal Investigator: Mariasanta Napolitano, MD Hematology Unit- University of Palermo
  More Information

Additional Information:
Publications:

Responsible Party: Napolitano Mariasanta, Assistant Professor (ricercatore td), University of Palermo
ClinicalTrials.gov Identifier: NCT02032134     History of Changes
Other Study ID Numbers: CUP: G33F1100003000
First Submitted: January 7, 2014
First Posted: January 9, 2014
Last Update Posted: October 18, 2017
Last Verified: October 2017

Keywords provided by Napolitano Mariasanta, University of Palermo:
Cryopreserved platelets, thrombocytopenia, DMSO

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Dimethyl Sulfoxide
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action