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

NCT02032134 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2017-10-18

No results posted yet for this study

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.

Conditions

  • Thrombocytopenia
  • Primary Thrombocytopenia,Unspecified
  • Thrombocytopenia Chemotherapy Induced

Interventions

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

Sponsors & Collaborators

  • Regione Sicilia

    collaborator UNKNOWN

  • Napolitano Mariasanta

    lead OTHER

Principal Investigators

  • Sergio Siragusa, MD · Hematology Unit- University of Palermo

  • Mariasanta Napolitano, MD · Hematology Unit- University of Palermo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02032134 on ClinicalTrials.gov