A Phase 3 Randomized, Double-Blind Study Comparing Etamsylate to Placebo to Prevent Bleeding in Adults Undergoing Hematopoietic Stem Cell Transplantation

What this Trial Is About

Researchers are evaluating the use of etamsylate compared to a placebo to prevent bleeding complications in patients with thrombocytopenia after hematopoietic stem cell transplantation. This phase 3, randomized, double-blind, placebo-controlled study focuses on patients aged 18 to 70 years who have low platelet counts following transplantation. The main goal is to reduce the incidence of death or significant bleeding within 30 days after treatment. Participants will receive either etamsylate or a placebo through intravenous infusion twice daily. Etamsylate is diluted with 100 ml of 0.9% sodium chloride injection for administration. The study compares these two treatments over a 30-day period to assess their effects on bleeding events and the need for platelet transfusions. During the study, participants will be closely monitored for bleeding events of WHO grade 2 or higher and any deaths. Researchers will also track the number of days participants remain free from significant bleeding and record how many platelet transfusions are needed. Safety and side effects of etamsylate versus placebo will be evaluated. The study requires participants to provide informed consent and meet specific organ function and coagulation criteria. The overall study duration includes a 30-day follow-up after treatment begins.

Comparison of Etamsylate Versus Placebo to Prevent Bleeding in HSCT