The purpose of this study is to evaluate the usefulness of antifibrinolytic therapy with tranexamic acid (TXA) in preventing bleeding in patients who are thrombocytopenic due to primary bone marrow disorders or chemotherapy, immunotherapy and/or radiation therapy.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
330
Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, TXA 1.0 gram will be administered. When given PO, TXA 1.3 grams will be administered
Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, Normal Saline will be administered. When given PO, placebo pills will be administered
University of North Carolina
Chapel Hill, North Carolina, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Washington
Seattle, Washington, United States
Bleeding Within 30 Days
Proportion of patients with bleeding of WHO grade 2 or above, over the study period of 30 days after activation of study drug.
Time frame: 30 days after activation of study drug
Number of Platelet Transfusions
Number of platelet transfusions per patient during the first 30 days post prescription activation of study drug
Time frame: 30 days after activation of study drug
Number of Days Alive and Without WHO Grade 2 Bleeding
Number of days alive and without WHO grade 2 bleeding or greater during the first 30 days post activation of study drug
Time frame: during the first 30 days post activation of study drug
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.