Can a simple drug stop bleeding in stem cell patients?
NCT ID NCT07442513
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether etamsylate, a drug that helps blood clot, can prevent serious bleeding in people who have low platelets after a stem cell transplant. About 404 adults will receive either etamsylate or a placebo, and researchers will track who has a major bleed or dies within 30 days. The goal is to see if etamsylate reduces bleeding risk by at least 14% compared to placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 404 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital, College of Medicine, Zhejiang University
RECRUITINGHangzhou, Zhejiang, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a bone drug plus immune signal stop blood cancer from returning after transplant?
- A diet tweak may boost platelets in a bleeding disorder
- Can tailored drug dosing make stem cell transplants safer?
- A phone call from a survivor: could peer support calm transplant anxiety?
- Can gut bacteria help rebuild immunity after stem cell transplants?
- Could a platelet-boosting drug shorten recovery after stem cell transplants?