This randomized phase II trial studies how well aminocaproic acid works compared with platelet transfusions in preventing bleeding in patients with thrombocytopenia and hematologic malignancies. Thrombocytopenia is a condition in which there is a lower-than-normal number of platelets in the blood and may result in easy bruising and excessive bleeding. Aminocaproic acid may increase low blood cell counts caused by hematologic malignancies. It is not yet known whether aminocaproic acid is more effective than platelet transfusion in preventing bleeding in patients with thrombocytopenia and hematologic malignancies.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02074436.
PRIMARY OBJECTIVES:
I. To compare the proportion of patients who develop major bleeding episodes (World Health Organization [WHO] grades 3-4) in the group randomized to receive prophylactic epsilon aminocaproic acid (EACA) (aminocaproic acid) versus standard of care prophylactic platelet transfusions.
SECONDARY OBJECTIVES:
I. To compare the proportion of patients who develop any bleeding episode in the group randomized to receive prophylactic EACA versus standard of care prophylactic platelet transfusions.
II. To compare, according to treatment with prophylactic EACA or prophylactic platelet transfusions, the total number of units of platelet transfused.
III. To compare the quality of life in both arms of the study.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo standard of care prophylactic platelet transfusions for 6 months in the absence of unacceptable toxicity.
ARM B: Patients receive aminocaproic acid orally (PO) twice daily (BID) for 6 months in the absence of unacceptable toxicity.
After completion of study, patients are followed up at 2 weeks, at 30 days, every 12 weeks for 6 months, and then periodically for 2 years.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationEmory University Hospital/Winship Cancer Institute
Principal InvestigatorAna Gabriela Antun
