MEG-002: Exploratory clinical study in thrombocytopenic patients

JRCT ID: jRCT2053210068

Registered date:19/08/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Thrombocytopenia
• Date of first enrollment: 19/08/2021
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Platelet transfusion (Intravenously infused at 3 or 10 units using a blood transfusion set.)

Outcome(s)

• Primary Outcome: Safety (AE, ADR), Effecacy (CCI)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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)

Exclude 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

Related Information

• Primary Sponsor: Takao Kazumasa