Avatrombopaq In Patients With Cirrhosis

Phase 4

• Conditions: Thrombocytopenia; Drugs; Cirrhosis, Liver; Procedural Bleeding
• Interventions: Drug: Doptelet Pill

• Registration Number: NCT04845659
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-04-11
• Study First Submitted QC: 2021-04-11
• Last Update Submitted: 2021-04-11
• Study First Posted: 2021-04-15
• Last Update Posted: 2021-04-15
• Study Start: 2021-06-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Doptelet Pill	Avatrombopaq administration

Primary Outcome Measures

Name	Time	Method
Adverse Events	3 months postprocedural	Mortality, bleedning, blood clots, readmission, reoperation