Efficacy of Mirasol-treated Apheresis Platelets in Patients With Hypoproliferative Thrombocytopenia (NCT02964325) | Clinical Trial Compass
TerminatedNot Applicable
Efficacy of Mirasol-treated Apheresis Platelets in Patients With Hypoproliferative Thrombocytopenia
Stopped: Based interim analysis results, Data Monitoring Committee did not believe the primary efficacy endpoint would be met. No patient safety concerns.
United States422 participantsStarted 2017-05-05
Plain-language summary
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.
Who can participate
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
✓. 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
✕. Treatment with pathogen-reduced blood products within previous 6 months
What they're measuring
1
Days of ≥ Grade 2 Bleeding
Timeframe: From the first post-randomization platelet transfusion through 28 days following the first transfusion.
. 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