Last updated on February 2019

Thrombosomes in Bleeding Thrombocytopenic Patients

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Blood disorder | Thrombocytopenia | Aplastic Anemia
  • Age: Between 18 - 68 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Adults up to 68 y/o with any of following: acute leukemia (ALL or AML), myelodysplasia, aplasia, and/or therapy (chemotherapy or radiation) induced bone marrow aplasia or hypoplasia with thrombocytopenia (platelet count 5,000 and 70,000/L) for a minimum of 2 days. May include bone marrow transplant or peripheral or cord blood stem cell recipients, but not subjects with Graft-vs-Host disease.
  • Hospitalized patients (or willing to be hospitalized for 24 hours after Rx) with Modified WHO Grade 1 (subset) or Grade 2 Bleeding Score or at risk for same within 4 weeks of screening. The Grade 1 subset includes patients who have either epistaxis, hematuria, oral petechiae, or bleeding at invasive or other wound sites.
  • No platelet inhibitor drugs within 5 days prior to infusion and during the immediate study 6 Day follow-up period.

Exclusion Criteria:

  • Hx or condition related to thrombosis, embolism or vascular occlusion/ischemia, including but not limited to: TIA, stroke, MI, stent placement, valve replacement and/or repair
  • Currently with an active acute infection, or suspected infection, a single oral temperature of 101 F or a temperature of 100.4F sustained over a 1 h period in past 24 h. Subjects on prophylactic antibiotics are not excluded from study
  • Coagulopathy or receiving anticoagulants that result in PT or aPTT values greater than 1.3 X upper limit of normal or elevated D-dimer of decreased fibrinogen
  • History of any inherited coagulation or platelet function, disorder or ITP, TTP, or HUS
  • Receipt of tranexamic acid or other antifibrinolytics within 48 hrs prior to infusion
  • Rx with an investigational drug w/in 1 month of infusion, other than for treatment of their underlying disease

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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