Study on the Efficacy and Safety of Avatricopal in Patients With CLD Complicated With Thrombocytopenia

Launched by BEIJING DITAN HOSPITAL · Oct 14, 2024

Keywords

ClinConnect Summary

This is a single-center, single-arm, prospective study. Patients with chronic liver disease undergoing selective invasive and minimally invasive surgery combined with thrombocytopenia. After enrollment, liver disease treatment was supplemented with avatripopal for 5 days. The baseline demographic data and biochemical data of the subjects were collected. Biochemical indexes of avatripopal were monitored during treatment and after withdrawal. The proportion of patients with platelet count ≥50×10\^9/L on the day of selective invasive and minimally invasive surgery was analyzed. The incidence o...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Voluntarily join the study and sign the informed consent;
• • Age ≥18 years old, male or female;
• • Baseline platelet count \< 50×10\^9/L;
• • Patients with chronic liver disease undergoing elective invasive and minimally invasive surgery;
• • No fertility requirements.
• Exclusion Criteria:
• • History of arterial or venous thrombosis within 6 months prior to baseline;
• • Plan to receive platelet transfusion or platelet-containing blood products within 7 days prior to baseline visit;
• • Anticoagulant or antiplatelet therapy cannot be suspended before surgery according to the standard (low-dose aspirin is allowed to continue);
• • currently receiving treatment with recombinant human thrombopoietin or thrombopoietin receptor agonists (such as rhTPO, Etopopal, or romipristine);
• • The subjects had severe arteriosclerosis, cerebral thrombosis tendency, coronary artery stenosis \> 70%;
• • Patients with a history of arterial or venous thrombosis within 6 months before enrollment;
• • Patients with known portal vein blood flow velocity \< 10 cm/s or previous portal vein thrombosis within 6 months before enrollment;
• • Prior to enrollment, any known primary blood history (e.g., immune thrombocytopenia, myelodysplastic syndrome, aplastic anemia);
• • A known history of hereditary prethrombotic syndrome prior to admission (e.g., VLeiden mutation, prothrombin G20210A mutation, or hereditary antithrombin III (ATIII) deficiency);
• • A history of major cardiovascular disease within the 6 months prior to enrollment (e.g., aggravated congestive heart failure, arrhythmias known to increase the risk of thromboembolic events \[such as atrial fibrillation\], coronary or peripheral arterial stenting or angioplasty, and coronary or peripheral arterial bypass grafting);
• • the subject is allergic to avatripopal or any of its excipients;
• • Exclude vulnerable people with mental disorders and other disabilities
• • The investigator believes that accompanying medical history may affect the safe completion of the study.