American Trial Using Tranexamic Acid in Thrombocytopenia

Inclusion criteria (all must be met):

• Must be ≥ 18 years of age
• Confirmed diagnosis of a hematologic malignancy or aplasia
• Undergoing or planned chemotherapy, immunotherapy, or hematopoietic stem cell transplantation
• Anticipated to have hypoproliferative thrombocytopenia resulting in a platelet count of ≤ 10,000/microliters for ≥ 5 days
• Able to provide informed consent and comply with treatment and monitoring, or having a Legally Authorized Representative (LAR)

Exclusion criteria (none can be present):

• 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