Comparison of Etamsylate Versus Placebo to Prevent Bleeding in HSCT
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFirst Affiliated Hospital of Zhejiang University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
etamsylate
Drugetamsylate Injection, administer by intravenous infusion, diluted with 100ml of 0.9% Sodium Chloride Injection, twice daily.
Placebo
Drug0.9% Sodium Chloride Injection, 100 ml, twice daily, intravenous drip
Treatment groups
404 Participants
are divided into 2 treatment groupsGroup A: etamsylateExperimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
30 daysSecondary outcomes
1
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.
Time frame
30 days2
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.Sponsors and contacts
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Source ClinicalTrials.gov