Actively Recruiting

Phase 3
Age: 18Years - 70Years
All Genders
NCT07442513

Comparison of Etamsylate Versus Placebo to Prevent Bleeding in HSCT

Led by First Affiliated Hospital of Zhejiang University · Updated on 2026-03-02

404

Participants Needed

1

Research Sites

97 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Comparison of Etamsylate Versus Placebo to Prevent Bleeding in HSCT

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 70 years inclusive
  • Diagnosis of a hematological disease requiring hematopoietic stem cell transplantation
  • Expected platelet count 64; 10 x 10�B9/L persisting for 5 days or more
  • Normal coagulation function
  • Adequate organ function: AST and ALT 64; 3 times the Upper Limit of Normal, Total Bilirubin 64; 2 times Upper Limit of Normal; Serum Creatinine 64; 2 times Upper Limit of Normal; Creatinine Clearance 50 mL/min by Cockcroft-Gault formula; Left Ventricular Ejection Fraction 50% measured by Echocardiography
  • Voluntary signed informed consent with ability to understand and comply with study requirements
Not Eligible

You will not qualify if you...

  • Diagnosis of acute promyelocytic leukemia
  • Pregnant or breastfeeding women, or women of childbearing potential unwilling to use effective contraception
  • Presence of active bleeding or infection
  • History of primary immune thrombocytopenia or hemolytic uremic syndrome
  • Known hereditary or acquired hemorrhagic disorders
  • Receiving anticoagulant or antiplatelet therapy
  • Severe cardiac insufficiency (EF < 60%) or severe arrhythmias including significant QTc prolongation, ventricular tachycardia, atrial fibrillation, second-degree heart block, recent myocardial infarction, or symptomatic coronary artery disease
  • Severe liver impairment (ALT, TBIL > 3 times Upper Limit of Normal)
  • Severe pulmonary insufficiency
  • Severe renal insufficiency (Creatinine > 2 times Upper Limit of Normal or creatinine clearance < 50 ml/min)
  • Mental disorders or conditions preventing informed consent and study compliance
  • Other investigator-determined reasons for ineligibility

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Actively Recruiting

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Research Team

Y

Yi Luo

CONTACT

L

Luxin Yang

CONTACT

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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