Comparison of Etamsylate Versus Placebo to Prevent Bleeding in HSCT

Sponsor
First Affiliated Hospital of Zhejiang University
Study ID
NCT07442513
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 16, 2025
Status verified
Feb 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
404 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: etamsylate
    Etamsylate Injection: Administer by intravenous infusion, diluted with 100ml of 0.9% Sodium Chloride Injection, twice daily.
  • Placebo Comparator: placebo
    0.9% Sodium Chloride Injection, 100 ml, twice daily, intravenous drip

Primary Outcome Measure

WHO grade 2 or higher bleeding events or death. [ Time Frame: 30 days ]

Central Contacts

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