Hematopoietic Stem Cell TransplantationPhase 3NCT07442513
Comparison of Etamsylate Versus Placebo to Prevent Bleeding in HSCT
A Phase 3 study testing etamsylate in people with Hematopoietic Stem Cell Transplantation and Thrombocytopenia, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation, Thrombocytopenia
- What is being tested?
- etamsylate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 404 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2025to 31 Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang
Yi Luo, 86-13666609126, luoyijr@zju.edu.cn
Luxin Yang, 86-13588756650, yangluxin2016@163.com
About this study
Official title: Comparison of Etamsylate Versus Placebo to Prevent Bleeding in Hematopoietic Stem Cell Transplantation Recipients：a Randomized, Double-blind, Phase 3, Clinical Study
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.
Read the detailed description
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. The primary endpoint is the incidence of death or bleeding events (WHO grade ≥2) within 30 days. Secondary endpoints focus on the safety profile of etamsylate versus placebo.
- Being tested
- etamsylate, Placebo
- Keywords
- etamsylate, Hematopoietic Stem Cell Transplantation recipients, thrombocytopenia, bleeding events
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etamsylateDrug
etamsylate Injection, administer by intravenous infusion, diluted with 100ml of 0.9% Sodium Chloride Injection, twice daily.
PlaceboDrug
0.9% Sodium Chloride Injection, 100 ml, twice daily, intravenous drip
| Study group | Role | What they receive |
|---|---|---|
| etamsylate | Experimental | Etamsylate Injection: Administer by intravenous infusion, diluted with 100ml of 0.9% Sodium Chloride Injection, twice daily. Receives: Drug: etamsylate |
| placebo | Placebo comparator | 0.9% Sodium Chloride Injection, 100 ml, twice daily, intravenous drip Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (2)
The number of days without WHO grade 2 or higher bleeding events
The number of days without WHO grade 2 or higher bleeding events within 30 days of medication administration. Etamsylate will be considered effective compared to placebo when the number of days without WHO grade 2 or higher bleeding events is 2 days more in the experimental group than in the placebo group.
Measured: 30 days
The number of platelet transfusions
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start16 Dec 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 404 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Luo, First Affiliated Hospital of Zhejiang University
- Investigators
- Yi Luo, Principal investigator, The First Affiliated Hospital, College of Medicine, Zhejiang University Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442513
- Sponsor's protocol ID
- ZJU-HSCT-ETA
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Etamsylate Versus Placebo to Prevent Bleeding in Hematopoietic Stem Cell Transplantation Recipients：a Randomized, Double-blind, Phase 3, Clinical Study
- ClinicalTrials.gov ID
- NCT07442513
- Acronym / sponsor ID
- ZJU-HSCT-ETA
- Keywords
- etamsylate, Hematopoietic Stem Cell Transplantation recipients, thrombocytopenia, bleeding events
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 404 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. The primary endpoint is the incidence of death or bleeding events (WHO grade ≥2) within 30 days. Secondary endpoints focus on the safety profile of etamsylate versus placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| etamsylate | Experimental | Drug: etamsylateEtamsylate Injection: Administer by intravenous infusion, diluted with 100ml of 0.9% Sodium Chloride Injection, twice daily. |
| placebo | Placebo comparator | Drug: Placebo0.9% Sodium Chloride Injection, 100 ml, twice daily, intravenous drip |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| etamsylateetamsylate Injection, administer by intravenous infusion, diluted with 100ml of 0.9% Sodium Chloride Injection, twice daily. | Drug | etamsylate |
| Placebo0.9% Sodium Chloride Injection, 100 ml, twice daily, intravenous drip | Drug | placebo |
Primary outcome
WHO grade 2 or higher bleeding events or death.
Time frame: 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.
2 secondary outcomes
The number of days without WHO grade 2 or higher bleeding events
Time frame: 30 days
The number of platelet transfusions
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yi Luo principal investigator
The First Affiliated Hospital, College of Medicine, Zhejiang University Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing etamsylate in people with Hematopoietic Stem Cell Transplantation and Thrombocytopenia, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Luo (86-13666609126, luoyijr@zju.edu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WHO grade 2 or higher bleeding events or death. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.