Avatrombopaq In Patients With Cirrhosis

Cirrhosis, Liver Clinical Trial

— AIPAC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04845659
• Other study ID #: AIPAC21
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 1, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: April 2021
• Source: Hvidovre University Hospital
• Contact: Christian Snitkjær, M.B.
• Phone: +4523670279
• Email: christian_snit[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Fibrosis
• Liver Cirrhosis
• Procedural Bleeding
• Thrombocytopenia
• Thrombocytopenia; Drugs

Intervention

Drug:
• Doptelet Pill
40 mg or 60 mg Doptelet orally 10-13 days before planned procedure.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Mortality, bleedning, blood clots, readmission, reoperation	3 months postprocedural