Comparison of Etamsylate Versus Placebo to Prevent Bleeding in HSCT

NCT07442513 | Recruiting Phase 3

• 1 other identifier: ZJU-HSCT-ETA
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hematopoietic Stem Cell Transplantation; Thrombocytopenia

Keywords

etamsylate; Hematopoietic Stem Cell Transplantation recipients; thrombocytopenia; bleeding events

Outcome Measures

Primary Outcomes (1)

• WHO grade 2 or higher bleeding events or death.

  The incidence of WHO grade 2 or higher bleeding events or death within 30 days of medication administration. Etamsylate will be considered effective compared to placebo when the incidence in the experimental group is 14.2% lower than that in the placebo group.

  30 days

Secondary Outcomes (2)

• The number of days without WHO grade 2 or higher bleeding events

  30 days

• The number of platelet transfusions

  The number of platelet transfusions within 30 days of medication administration. Etamsylate will be considered effective compared to placebo when the number of platelet transfusions in the experimental group is 2.5 fewer than in the placebo group.

Study Arms (2)

etamsylate

EXPERIMENTAL

Etamsylate Injection: Administer by intravenous infusion, diluted with 100ml of 0.9% Sodium Chloride Injection, twice daily.

Drug: etamsylate

placebo

PLACEBO COMPARATOR

0.9% Sodium Chloride Injection, 100 ml, twice daily, intravenous drip

Drug: Placebo

Interventions

etamsylate DRUG

etamsylate Injection, administer by intravenous infusion, diluted with 100ml of 0.9% Sodium Chloride Injection, twice daily.

etamsylate

Placebo DRUG

0.9% Sodium Chloride Injection, 100 ml, twice daily, intravenous drip

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Thrombocytopenia

Interventions

Ethamsylate

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Yi Luo

  The First Affiliated Hospital, College of Medicine, Zhejiang University Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Luo

CONTACT

86-13666609126; luoyijr@zju.edu.com

Luxin Yang

CONTACT

86-13588756650; yangluxin2016@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 2, 2026
• Study Start: December 16, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)