Avatrombopaq In Patients With Cirrhosis (AIPAC)

Hvidovre University Hospital

Status and phase: Unknown; Phase 4

Conditions: Procedural Bleeding; Cirrhosis, Liver; Thrombocytopenia; Drugs

Treatments: Drug: Doptelet Pill

Study type: Interventional

Funder types: Other

Identifiers

NCT04845659

AIPAC21

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Intervention

Experimental group

Description:

Avatrombopaq administration

Treatment:

Drug: Doptelet Pill