NCT07442513 Comparison of Etamsylate Versus Placebo to Prevent Bleeding in HSCT
| NCT ID | NCT07442513 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | First Affiliated Hospital of Zhejiang University |
| Condition | Hematopoietic Stem Cell Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 404 participants |
| Start Date | 2025-12-16 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 404 participants in total. It began in 2025-12-16 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Yi Luo
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital, College of Medicine, Zhejiang University Principal Investigator
Frequently Asked Questions
Who can join the NCT07442513 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Hematopoietic Stem Cell Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07442513 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 404 participants.
Is NCT07442513 currently recruiting?
Yes, NCT07442513 is actively recruiting participants. Contact the research team at luoyijr@zju.edu.com for enrollment information.
Where is the NCT07442513 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07442513 clinical trial?
NCT07442513 is sponsored by First Affiliated Hospital of Zhejiang University. The principal investigator is Yi Luo at The First Affiliated Hospital, College of Medicine, Zhejiang University Principal Investigator. The trial plans to enroll 404 participants.