NCT07442513

Comparison of Etamsylate Versus Placebo to Prevent Bleeding in HSCT

Comparison of Etamsylate Versus Placebo to Prevent Bleeding in Hematopoietic Stem Cell Transplantation Recipients：a Randomized, Double-blind, Phase 3, Clinical Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 404 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The primary endpoint is the incidence of death or bleeding events (WHO grade ≥2) within 30 days. Secondary endpoints focus on the safety profile of etamsylate versus placebo.

Conditions

• Hematopoietic Stem Cell Transplantation
• Thrombocytopenia

Interventions

Type	Name	Description
DRUG	etamsylate	etamsylate Injection, administer by intravenous infusion, diluted with 100ml of 0.9% Sodium Chloride Injection, twice daily.
DRUG	Placebo	0.9% Sodium Chloride Injection, 100 ml, twice daily, intravenous drip

Timeline

• Start date: 2025-12-16
• Primary completion: 2027-10-31
• Completion: 2027-10-31
• First posted: 2026-03-02
• Last updated: 2026-03-02

Locations

1 site across 1 country: China