RecruitingPhase 3NCT07442513

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

Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

404 participants

Start Date

Dec 16, 2025

Study Type

INTERVENTIONAL

Conditions

Thrombocytopenia Hematopoietic Stem Cell Transplantation

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria6

Age between 18 and 70 years (inclusive), regardless of gender;
Patients diagnosed with a hematological disease requiring hematopoietic stem cell transplantation;
Expected platelet count ≤ 10 x 10⁹/L persisting for 5 days or more;
Normal coagulation function;
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);
Voluntary provision of signed informed consent, with the ability to understand and comply with all study requirements.

Exclusion Criteria11

Diagnosis of acute promyelocytic leukemia confirmed according to WHO diagnostic criteria;
Pregnant or breastfeeding women, and women of childbearing potential unwilling to use effective contraception;
Presence of active bleeding or infection;
History of diagnosed primary immune thrombocytopenia or hemolytic uremic syndrome;
Patients with known hereditary or acquired hemorrhagic disorders;
Patients receiving anticoagulant or antiplatelet therapy;
Patients with severe cardiac insufficiency (left ventricular ejection fraction \[EF\] \< 60%); or severe arrhythmias: history of clinically significant QTc prolongation (male \> 450 ms; female \> 470 ms), ventricular tachycardia, atrial fibrillation, second-degree heart block; myocardial infarction within 1 year prior to enrollment; or symptomatic coronary artery disease requiring medication; patients with severe liver impairment (liver function indices \[ALT, TBIL\] \> 3 times the upper limit of normal \[ULN\]);
Patients with severe pulmonary insufficiency (obstructive and/or restrictive ventilatory defects);
Patients with severe renal insufficiency (renal function index \[Cr\] \> 2 times ULN); or 24-hour urinary creatinine clearance rate (Ccr) \< 50 ml/min;
Patients with mental disorders or other conditions preventing provision of informed consent and compliance with study treatment and procedural requirements;
Other reasons deemed by the investigator to make the patient ineligible for inclusion.

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