Efficacy of Mirasol-treated Apheresis Platelets in Patients With Hypoproliferative Thrombocytopenia

Stopped early · Not applicable

Conditions studied: Hematologic Malignancies, Hypoproliferative Thrombocytopenia

In brief

This is a prospective, multi-center, controlled, randomized, non-inferiority study to evaluate the clinical effectiveness of Conventional versus Mirasol-treated apheresis platelets in subjects with hypoproliferative thrombocytopenia who are expected to have platelet count(s) ≤ 10,000/μL requiring ≥ 2 platelet transfusions.

Key facts

Study ID

NCT02964325

Run by

Terumo BCTbio

People needed

422

Starts

2017-05-05

Expected to finish

2020-06-25

Last updated by the study team

2021-08-19

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• Treatment with pathogen-reduced blood products within previous 6 months
• Subject has been previously enrolled in this study and received at least 1 per protocol PLT transfusion
• a.) Subject is receiving therapeutic doses of antiplatelet agents, antifibrinolytics, and/or PLT specific growth factors within 10 days prior to randomization or b.) Subject is receiving therapeutic doses of anticoagulant, pro-coagulant or antithrombotic agents within 10 days prior to randomization. Subjects can be included if receiving the following: prophylactic dosing of anticoagulants (heparin, any low molecular weight heparin, enoxaparin, or fondaparinux), anticoagulants/thrombolytic agents used to maintain or re-establish the patency of catheters (heparin flushes or tissue-plasminogen activase [TPA], therapeutic doses of anticoagulants with a half-life of < 24 hours if it will be discontinued at least 24 hours prior to the first study transfusion, single periprocedural doses of anticoagulants with a half-life of < 24 hours or low dose aspirin (81 mg per day)
• Subject has ≥ grade 2 bleeding at the time of randomization
• Planned administration of bedside LR PLT transfusion(s)
• Presently with or a history of acute promyelocytic leukemia (APML), idiopathic thrombocytopenic purpura (ITP), thrombotic thrombocytopenic purpura (TTP), or hemolytic uremic syndrome (HUS)
• HLA and/or HPA-alloimmunization and/or platelet refractory as determined by the investigator
• Hypersplenism as evidenced by splenomegaly based on investigator assessment at baseline
• 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 (i.e, 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

Where it is running

• Children's National Medical Center — Washington D.C., District of Columbia, United States
• University of Florida Health Shands Hospital — Gainesville, Florida, United States
• Emory University/Children's Hospital of Atlanta — Atlanta, Georgia, United States
• University of Iowa — Iowa City, Iowa, United States
• John Hopkins University School of Medicine/Johns Hopkins Kimmel Cancer Center — Baltimore, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Robert Wood Johnson Medical School/RWJ University Hospital — New Brunswick, New Jersey, United States
• University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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