Comparison of Etamsylate Versus Placebo to Prevent Bleeding in HSCT

ConditionsHematopoietic Stem Cell Transplantation Thrombocytopenia

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

Qualifiers

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

Treatments tested in this trial

etamsylate
Placebo

Treatment groups

404 Participants

are divided into 2 treatment groups

Sponsors and collaborators

First Affiliated Hospital of Zhejiang University

Lead sponsor

Source ClinicalTrials.gov