Comparison of Etamsylate Versus Placebo to Prevent Bleeding in HSCT
This study employs a prospective, randomized, double-blind, placebo-controlled design. It aims to compare the efficacy of etamsylate versus placebo in preventing bleeding complications in patients with thrombocytopenia following hematopoietic stem cell transplantation.
| Condition(s) | Hematopoietic Stem Cell Transplantation, Thrombocytopenia |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | This study employs a prospective, randomized, double-blind, placebo-controlled design. It aims to compare the efficacy of etamsylate versus placebo in preventing bleeding complications in patients with thrombocytopenia following hematopoietic stem cell transplantation. |
| Who can participate | Inclusion Criteria: 1. Age between 18 and 70 years (inclusive), regardless of gender; 2. Patients diagnosed with a hematological disease requiring hematopoietic stem cell transplantation; 3. Expected platelet count ≤ 10 x 10⁹/L persisting for 5 days or more; 4. Normal coagulation function; 5. Adequate organ function: Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3 times the Upper Limit of Normal (ULN), Total Bilirubin ≤ 2 x ULN; Serum Creatinine ≤ 2 x ULN; Creatinine Clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula); Left Ventricular Ejection Fraction (LVEF) ≥ 50% as measured by Echocardiography (ECHO); 6. Voluntary provision of signed informed consent, with the ability to understand and comply with all study requirements. Exclusion Criteria: 1. D |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | First Affiliated Hospital of Zhejiang University |
| Locations | Hangzhou, Zhejiang, China |
| Start date | 2025-12-16 |
| NCT ID | NCT07442513 |
| Official listing | https://clinicaltrials.gov/study/NCT07442513 |