Recruiting
Phase 3
Comparison of Etamsylate Versus Placebo to Prevent Bleeding in HSCT
Condition(s) studied
Hematopoietic Stem Cell TransplantationThrombocytopenia
Investigational drug(s) / intervention(s)
etamsylatePlacebo
etamsylate: etamsylate Injection, administer by intravenous infusion, diluted with 100ml of 0.9% Sodium Chloride Injection, twice daily.
Placebo: 0.9% Sodium Chloride Injection, 100 ml, twice daily, intravenous drip
Study 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
Inclusion Criteria:
1. Age between 18 and 70 years (inclusive), regardless of gender;
2. Patients diagnosed with a hematological disease requiring hematopoietic stem cell transplantation;
3. Expected platelet count ≤ 10 x 10⁹/L persisting for 5 days or more;
4. Normal coagulation function;
5. 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);
6. Voluntary provision of signed informed consent, with the ability to understand and comply with all study requirements.
Exclusion Criteria:
1. Diagnosis of acute promyelocytic leukemia confirmed according to WHO diagnostic criteria;
2. Pregnant or breastfeeding women, and women of childbearing potential unwilling to use effective contraception;
3. Presence of active bleeding or infection;
4. History of diagnosed primary immune thrombocytopenia or hemolytic uremic syndrome;
5. Patients with known hereditary or acquired hemorrhagic disorders;
6. Patients receiving anticoagulant or antiplatelet therapy;
7. 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 \[ULN\]);
8. Patients with severe pulmonary insufficiency (obstructive and/or restrictive ventilatory defects);
9. Patients with severe renal insufficiency (renal function index \[Cr\] \> 2 times ULN); or 24-hour urinary creatinine clearance rate (Ccr) \< 50 ml/min;
10. Patients with mental disorders or other conditions preventing provision of informed consent and compliance with study treatment and procedural requirements;
11. Other reasons deemed by the investigator to make the patient ineligible for inclusion.
Primary outcome measure(s)
- WHO grade 2 or higher bleeding events or death. — 30 days
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.
Trial sites (1)
| Facility | City | Region | Status |
| The First Affiliated Hospital, College of Medicine, Zhejiang University |
Hangzhou |
Zhejiang |
Recruiting |
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