Thrombosomes® in Bleeding Thrombocytopenic Patients
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This study evaluates in a dose-escalation manner, the safety, and preliminary impact on bleeding, and the preliminary effect on coagulation measures of increasing doses of allogeneic Thrombosomes in thrombocytopenic patients.
The objectives of this trial, conducted in thrombocytopenic patients with modified World Health Organization (WHO) Grade 1* or 2 bleeding, assessing the safety of infusing increasing doses of allogeneic Thrombosomes in WHO bleeding and measures of coagulation.
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Ages Eligible for Study:
18 Years to 68 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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/μL) 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.
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 ≥ 100.4°F 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