American Trial Using Tranexamic Acid in Thrombocytopenia

Exclusion Criteria

• •Diagnosis of acute promyelocytic leukemia undergoing induction chemotherapy
• •History of ITP, TTP or HUS
• •Subjects receiving L-asparaginase as part of their current cycle of treatment
• •Subjects with a past history or current diagnosis of arterial or venous thromboembolic disease including acute coronary syndrome, peripheral vascular disease and retinal arterial or venous thrombosis (except when a prior history of central line thrombosis has resolved)
• •Subjects with a diagnosis/previous history of sinusoidal obstruction syndrome (also called veno-occlusive disease)
• •Subjects receiving any pro-coagulant agents (e.g. DDAVP, recombinant Factor VIIa or Prothrombin Complex Concentrates (PCC) and/or an antifibrinolytic agent within 48 hours of enrollment, or with known hypercoagulable state
• •Known inherited or acquired bleeding disorder including, but not limited to:
• •* Acquired storage pool deficiency
• •* Paraproteinemia with platelet inhibition
• •Known inherited or acquired prothrombotic disorders, including antiphospholipid syndrome. Those with lupus anticoagulant or positive antiphospholipid serology without thrombosis are not excluded.
• •Subjects receiving anticoagulant therapy or anti-platelet therapy (except when receiving prophylactic anticoagulant or low dose aspirin therapy for prophylaxis only with a plan to discontinue when the platelet count falls below 50,000)
• •Patients with DIC according to the patient's physician
• •Subjects with WHO Grade 2 bleeding or greater within 48 hours prior to activation
• •Subjects requiring a platelet transfusion threshold \> 10,000/microliters at time of randomization
• •Subjects with anuria (defined as urine output \< 10mls/hr over 24 hours)
• •Subjects on dialysis
• •Subjects with creatinine ≥5.7mg/dL
• •Subjects who are pregnant or nursing or unwilling to use contraception during and for 30 days after taking the study drug (both males and females)
• •Subjects enrolled in other trials involving platelet transfusions, anti-fibrinolytics, platelet growth factors or other pro-coagulant agents.
• •Known allergy to tranexamic acid
• •Having been previously randomized in this study at any stage of their treatment
• •Subjects who are unwilling to accept blood or blood component transfusions