Thrombocytopenia
Conditions
Interventions
Platelet transfusion (Intravenously infused at 3 or 10 units using a blood transfusion set.)
Sponsors
Takao Kazumasa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Thrombocytopenic patients under stable medical conditions who have been diagnosed with any of the following diseases , - Aplastic anemia - Myelodysplastic syndrome - Leukemia (excluding induction therapy, early cytopenia after consolidation therapy and acute promyelocytic leukemia) - Solid cancer after chemotherapy (prolonged thrombocytopenia) 2) Patients whose platelet count is 20,000 / microL or less, or expected to be 20,000 / microL or less without blood transfusion, or patients who are at a risk of bleeding at 30,000 / microL or less 3) Patients who can wash out for 3 days or more after blood donation platelet transfusion before administration of MEG-002 4) Aged 18 years or older at the time of the informed consent 5) Gender: Not specified 6) Patients with written informed consent (and a surrogate in case of under 20)
Exclusion criteria
Exclusion criteria: 1) Patients with platelet transfusion refractoriness 2) Patients with a history of severe blood transfusion allergies such as anaphylaxis in the past 3) Patients with hemophilia or other blood coagulation disorders 4) Patients with symptomatic thrombosis or at risk of thrombosis 5) Patients with a history of pulmonary embolism and central hepatic vein occlusion 6) Patients with a history of thrombotic thrombocytopenic purpura, hemolytic uremic syndrome, or immune thrombocytopenic purpura 7) Patients with disseminated intravascular coagulation or sepsis 8) Splenomegaly (maximum ultrasound image diameter of 18 cm or more) 9) Patients requiring anticoagulant / antithrombotic therapy with anticoagulants and antiplatelet agents 10) Patients with moderate or sever renal dysfunction and/or hepatic dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (AE, ADR), Effecacy (CCI) | — |
Contacts
Public ContactKazumasa Takao
Megakaryon Corporation
Outcome results
None listed