Clinical Effectiveness of Standard Versus Mirasol-treated Apheresis Platelets in Patients with Hypoproliferative Thrombocytopenia

Purpose

To determine if the hemostatic efficacy of Mirasol-treated plasma stored Apheresis (Aph) PLTs are non-inferior to standard plasma stored Aph PLTs in patients with hypoproliferative thrombocytopenia requiring PLT transfusions.

Inclusion Criteria:

  1. Weight > 10 kg (22 lbs)
  2. Subject has a hematologic malignancy with hypoproliferative thrombocytopenia and is expected to have PLT count(s) ≤ 10,000/µL requiring ≥ 2 PLT transfusions
  3. Laboratory results within 5 days prior to anticipated initiation of the first post randomization PLT transfusion:

    1. Prothrombin time (PT) and/or international normalized ratio (INR) ≤ 1.3 × the upper limit of normal (ULN)
    2. Activated partial thromboplastin time (aPTT) ≤ 1.3 × ULN
    3. Fibrinogen ≥ 100 mg/dL
  4. Women of childbearing potential must have a negative pregnancy test and agree to practice a medically acceptable contraception regimen for the study duration. Women who are postmenopausal for at least 1 year (> 12 months since last menses) or are surgically sterilized do not require this test
  5. IC from the subject or assent from the subject and consent from a parent or guardian, if the subject is < 18 years of age

Exclusion Criteria:

  1. Previous treatment with pathogen-reduced blood products
  2. Subject has previously been enrolled in this study and received at least 1 per protocol PLT transfusion
  3. Subject is receiving anticoagulant, pro-coagulant or antithrombotic, antiplatelet agents, and/or PLT specific growth factors within 10 days prior to randomization
  4. Subject has ≥ grade 2 bleeding at the time of randomization
  5. Planned administration of bedside LR PLT transfusion(s)
  6. Subject is anticipated to need washed or volume reduced PLT during the course of this study
  7. Presently with or a history of acute promyelocytic leukemia (APML), idiopathic thrombocytopenic purpura (ITP), thrombotic thrombocytopenic purpura (TTP), or hemolytic uremic syndrome (HUS)
  8. Subject is receiving anticoagulant, pro-coagulant or antithrombotic, antiplatelet agents, and/or PLT specific growth factors within 10 days prior to randomization
  9. Splenomegaly (presence of a palpable spleen whose border could be felt more than 4 cm below the costal margin)
  10. History or diagnosis of a disease affecting hemostasis
  11. Currently taking, or participating in a clinical study involving PLT substitutes, PLT growth factors, or pharmacologic agents intended to enhance (ie, antifibrinolytic agents) or decrease PLT hemostatic function
  12. Acute or chronic medical disorder that, in the opinion of the investigator, would impair the ability of the subject to receive protocol treatment
  13. Subject is pregnant or lactating
  14. Inability of the subject to comply with study procedures and/or follow-up

Keywords

cancer, Thrombocytopenia

Principal Investigator

Randy A Brown, M.D.

Department

MD-HEMATOLOGY/ONCOLOGY

Contact Information

randy.brown@medicine.ufl.edu

352-733-0972


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