Treatment With Avatrombopaq in Patients With Cirrhosis Undergoing Small Invasive Procedure: A Prospective Case Series
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 主要终点
- Adverse Events
研究概览
简要总结
Thrombocytopenia is a frequent issue in patients with cirrhosis undergoing various types of procedures (e.g. liver biopsy, endoscopy and minor surgical interventions). Thrombocytopenia < 50*10^9/L increases the risk of perioperative and postoperative bleedning and might prevent patients with cirrhosis to undergo important procedures. Doptelet is a small molecular trombopoetin agonist, which results in proliferation and differentiation of megakaryocytes in the bone marrow resulting in increased levels of thrombocytes. It is given orally as a pill and is used to increase platelet count in patients with severe thrombocytopenia (< 50*10^9/L) and cirrhosis and thus not to normalize platelet count. This study investigates the safety and efficacy of Doptelet in patients with cirrhosis and thrombocytopenia (< 50*10^9/L) undergoing minor procedures like Transjugular Adjusted Liver Biopsy (TJALB) and gastroscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: >17 years and ≤80 years
- •ASA I-III
- •Patients who read, understood and signed informed consent.
- •Patients with a diagnosis of cirrhosis
- •Thrombocytopenia <50*109
- •The patient is scheduled for one of the following procedures: Transjugular Adjusted Liver Biopsy (TJALB), gastroscopy or percutan paracentesis of ascites in the following month.
排除标准
- •Patients who do not speak and understand Danish.
- •Patients who cannot cooperate within the trial.
- •Patients who did not sign an informed consent regardless of the cause.
- •Active drug abuse - to the discretion of the investigator.
- •Thrombocytes >50*10^9
- •Patients with hereditary trombolic diseases (e.g. Factor V Leiden, antithrombin deficiency, protein S and C deficiency, prothrombin G202110A mutation).
- •INR > 1,7
- •Ongoing infection verified by blood culture, clinical examination, and acute phase reactants (e.g. CRP)
研究组 & 干预措施
Intervention
Avatrombopaq administration
干预措施: Doptelet Pill (Drug)
结局指标
主要结局
Adverse Events
时间窗: 3 months postprocedural
Mortality, bleedning, blood clots, readmission, reoperation
次要结局
未报告次要终点
研究者
Christian Snitkjær
M.B.
Hvidovre University Hospital