Avatrombopaq In Patients With Cirrhosis

Study Overview
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Brief Summary
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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.

Official Title
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Treatment With Avatrombopaq in Patients With Cirrhosis Undergoing Small Invasive Procedure: A Prospective Case Series

Conditions
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Cirrhosis, Liver, Procedural Bleeding, Thrombocytopenia; Drugs

Intervention / Treatment
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* Drug: Doptelet Pill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Avatrombopaq administration | Drug: Doptelet Pill<br>* 40 mg or 60 mg Doptelet orally 10-13 days before planned procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Mortality, bleedning, blood clots, readmission, reoperation | 3 months postprocedural | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cirrhosis, Thrombocytopenia