PRevention Of BLeeding in hEmatological Malignancies With Antifibrinolytic (Epsilon Aminocaproic Acid)
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
STUDY BACKGROUND AND PURPOSE:
Patients with hematological malignancies (blood-related cancers) often develop
thrombocytopenia (low platelet count), which can be made worse by cancer treatment.
Preventive (prophylactic) platelet transfusion remains the standard of care for
thrombocytopenic patients. However, bleeding remains a significant problem in these patients,
affecting approximately 20% of patients with acute myeloid leukemia and 34-58% of
hematopoietic stem cell transplant recipients. Platelet transfusion refractoriness, the
repeated failure to obtain satisfactory response to platelet transfusions, is a common
problem. Alternatives to platelet transfusions are desperately needed for these patients.
Epsilon aminocaproic acid (EACA) blocks a process called fibrinolysis that is an essential
step in the bleeding process. EACA is approved by the FDA for the treatment of severe
bleeding-related diseases and complications. A small study has shown EACA to be well
tolerated and associated with low risk of bleeding in patients with hematological
malignancies.
This study will compare EACA versus standard prophylactic platelet transfusion for the
prevention of bleeding in thrombocytopenic patients with hematological malignancies.
STUDY DESCRIPTION:
This is Phase II study to compare EACA versus standard prophylactic platelet transfusion to
prevent bleeding in thrombocytopenic patients with hematological malignancies. Patients who
are eligible to take part must give their written agreement before they can be enrolled.
The study will enroll 100 patients who will be assigned randomly to take EACA twice daily or
to undergo standard prophylactic platelet transfusion. Patients will be followed for any
bleeding events, need for platelet transfusion, and any side effects experienced. Patients
will complete questionnaires to assess their quality of life while on the study.