Actively Recruiting
Comparison of Etamsylate Versus Placebo to Prevent Bleeding in Hematopoietic Stem Cell Transplantation Recipients: a Randomized, Double-blind, Phase 3 Clinical Study
Led by First Affiliated Hospital of Zhejiang University · Updated on 2026-03-02
404
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Comparison of Etamsylate Versus Placebo to Prevent Bleeding in HSCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years, any gender
- Diagnosed with a hematological disease requiring hematopoietic stem cell transplantation
- Expected platelet count of 10 x 10⁹/L or less lasting 5 days or more
- Normal blood clotting function
- Adequate organ function with AST and ALT less than or equal to 3 times upper normal limit, total bilirubin less than or equal to 2 times upper normal limit
- Serum creatinine less than or equal to 2 times upper normal limit
- Creatinine clearance of at least 50 mL/min
- Left ventricular ejection fraction of at least 50% measured by echocardiography
- Ability to understand and voluntarily sign informed consent and comply with study requirements
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia
- Pregnant or breastfeeding women or women unwilling to use effective contraception
- Active bleeding or infection at the time of enrollment
- History of primary immune thrombocytopenia or hemolytic uremic syndrome
- Known hereditary or acquired bleeding disorders
- Current use of anticoagulant or antiplatelet medications
- Severe heart problems including ejection fraction below 60%, serious arrhythmias, recent heart attack, or symptomatic coronary artery disease
- Severe liver impairment with ALT or total bilirubin more than 3 times upper normal limit
- Severe lung problems with obstructive or restrictive defects
- Severe kidney problems with serum creatinine over 2 times upper normal limit or creatinine clearance below 50 mL/min
- Mental disorders or other conditions preventing informed consent or compliance
- Other investigator-determined reasons making patient ineligible
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 30 days
Participants receive etamsylate or placebo by intravenous infusion twice daily to prevent bleeding after hematopoietic stem cell transplantation.
Daily administration with regular monitoring visits during treatment
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
Y
Yi Luo
L
Luxin Yang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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