Study on the Efficacy and Safety of Avatricopal in Patients With Chronic Liver Disease With Selective Invasive and Minimally Invasive Surgery Combined With Thrombocytopenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Proportion of patients with platelet count ≥50×10^9/L on the day of elective invasive and minimally invasive surgery.
研究概览
简要总结
In this study, patients with chronic liver disease undergoing selective invasive and minimally invasive surgery combined with thrombocytopenia were enrolled. After enrollment, liver disease treatment was supplemented with avatripopal for 5 days. 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 of adverse events was observed.
详细描述
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 of adverse events was observed. To investigate the efficacy and safety of avatripopal in chronic liver disease patients with thrombocytopenia undergoing elective invasive and minimally invasive surgery. To provide reference for related clinical treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Platelet count: <50×10^9/L
Patients with chronic liver disease undergoing elective invasive and minimally invasive surgery with concomitant thrombocytopenia, who meet the inclusion criteria and are treated with atorvastatin, were included in the study group for clinical observation. Eligibility for treatment, dosage selection (60 mg/day for PLT < 40×10^9/L, 40 mg/day for PLT 40-50×10^9/L), the standard treatment regimen of 5 consecutive days of oral administration, and timing of procedures (10 ± 3 days after treatment initiation) reflected routine clinical practice and were aligned with the drug's pharmacokinetic profile and prescribing information. Follow-up visits and data collection time points (baseline, day 5, day 10, and day 40) were standardized for the purposes of systematic data capture in this observational study.
结局指标
主要结局
Proportion of patients with platelet count ≥50×10^9/L on the day of elective invasive and minimally invasive surgery.
时间窗: 2024-2025
Proportion of patients with platelet count ≥50×10\^9/L on the day of elective invasive and minimally invasive surgery.
次要结局
- Adverse event rate(2024-2025)
研究者
Yao Xie
Head of Department
Beijing Ditan Hospital