American Trial Using Tranexamic Acid in Thrombocytopenia

The purpose of this study is to conduct a prospective, randomized, blinded, placebo
controlled trial to evaluate the usefulness of antifibrinolytic therapy with tranexamic acid
in preventing bleeding in patients who are thrombocytopenic due to primary bone marrow
disorders or chemotherapy, immunotherapy and/or radiation therapy. The results of this study
will change practice by providing evidence as to whether or not TXA is effective and safe
treatment when used as an adjunct to platelet transfusion therapy in the thrombocytopenic
patient.

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