Avatrombopaq In Patients With Cirrhosis

• Status: Not yet recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hvidovre University Hospital

Criteria

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)