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:
- Weight > 10 kg (22 lbs)
- Subject has a hematologic malignancy with hypoproliferative thrombocytopenia and is expected to have PLT count(s) ≤ 10,000/µL requiring ≥ 2 PLT transfusions
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Laboratory results within 5 days prior to anticipated initiation of the first post randomization PLT transfusion:
- Prothrombin time (PT) and/or international normalized ratio (INR) ≤ 1.3 × the upper limit of normal (ULN)
- Activated partial thromboplastin time (aPTT) ≤ 1.3 × ULN
- Fibrinogen ≥ 100 mg/dL
- 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
- 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:
- Previous treatment with pathogen-reduced blood products
- Subject has previously been enrolled in this study and received at least 1 per protocol PLT transfusion
- Subject is receiving anticoagulant, pro-coagulant or antithrombotic, antiplatelet agents, and/or PLT specific growth factors within 10 days prior to randomization
- Subject has ≥ grade 2 bleeding at the time of randomization
- Planned administration of bedside LR PLT transfusion(s)
- Subject is anticipated to need washed or volume reduced PLT during the course of this study
- Presently with or a history of acute promyelocytic leukemia (APML), idiopathic thrombocytopenic purpura (ITP), thrombotic thrombocytopenic purpura (TTP), or hemolytic uremic syndrome (HUS)
- Subject is receiving anticoagulant, pro-coagulant or antithrombotic, antiplatelet agents, and/or PLT specific growth factors within 10 days prior to randomization
- Splenomegaly (presence of a palpable spleen whose border could be felt more than 4 cm below the costal margin)
- History or diagnosis of a disease affecting hemostasis
- 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
- Acute or chronic medical disorder that, in the opinion of the investigator, would impair the ability of the subject to receive protocol treatment
- Subject is pregnant or lactating
- Inability of the subject to comply with study procedures and/or follow-up
Keywords
cancer, ThrombocytopeniaPrincipal Investigator
Randy A Brown, M.D.Department
MD-HEMATOLOGY/ONCOLOGY
Contact Information
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