Tranexamic Acid for the Prevention of Bleeding Complications in Pediatric Cancer Patients Undergoing Chemotherapy or Bone Marrow Transplant

Inclusion Criteria

• Patients must have a confirmed diagnosis of hematologic malignancy or solid tumor malignancy
• Patients must be undergoing or planned chemotherapy or BMT
• Patients will only be eligible to receive study drug or placebo during a predicted inpatient stay of =< 5 days
• Patients must be predicted to have thrombocytopenia =< 20,000/uL for >= 5 days
• Patient must have a platelet transfusion threshold of =< 10,000/uL (for hematologic or solid tumor malignancies who are not undergoing BMT) or =< 20,000/uL (for patients with hematologic or solid tumor malignancies who are undergoing BMT)
• Patients must be > 14 days beyond their last dose of PEG-asparaginase or Erwinia asparaginase
• Patients must be able to comply with treatment and monitoring

Exclusion Criteria

• Diagnosis of acute promyelocytic leukemia
• History of immune thrombocytopenic purpura (ITP), thrombotic thrombocytopenic purpura (TTP) or hemolytic uremic syndrome (HUS)
• History of inherited or acquired bleeding disorder
• History of inherited or acquired prothrombotic disorder
• Diagnosis of disseminated intravascular coagulopathy (DIC)
• Patient must not have WHO Grade 2 bleeding or greater within 48 hours prior to enrollment or study drug activation
• Patient must not have received PEG-asparaginase or Erwinia asparaginase within the 7 day period prior to enrollment. If one of these products is given within the 8-14 day period prior to enrollment patients are eligible if prothrombin time (PT), partial thromboplastin time (PTT), international normalized ratio (INR) and fibrinogen are obtained and are within 1.5 times the upper limits of normal
• Patient must not be receiving tranexamic acid or other anti-fibrinolytic agent or any other agent to promote hemostasis (which includes desmopressin acetate [DDAVP], recombinant factor VII, prothrombin complex concentrate, estrogen derivatives and progestins)
• Patient must not be receiving therapy with anticoagulation or antiplatelet therapy (which includes heparin infusion, enoxaparin, aspirin. If anticoagulant/antiplatelet therapy is discontinued when platelet count is < 50,000/uL patient will be eligible for enrollment)
• Patient must not be receiving platelet growth factors
• Patient has a current/prior history of thromboembolic event
• Patient has a current/prior history of sinusoidal obstruction disease
• Patient has visible blood in their urine
• Patient with renal dysfunction, hemodialysis or with anuria (defined as < 10 mL urine/hour over 24 hours)
• History of seizures
• Allergy to tranexamic acid
• Pregnancy
• Unwilling to accept blood transfusions
• Requires platelet transfusion threshold higher than study protocol (If the patient is enrolled on study and begins treatment with either the study drug or placebo, and subsequently requires a platelet transfusion threshold greater than the study protocol they will remain on study)