Avatrombopaq In Patients With Cirrhosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-06-01

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.

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Detailed Description

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Conditions

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Thrombocytopenia; Drugs Cirrhosis, Liver Procedural Bleeding

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

Avatrombopaq administration

Group Type EXPERIMENTAL

Doptelet Pill

Intervention Type DRUG

40 mg or 60 mg Doptelet orally 10-13 days before planned procedure.

Interventions

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Doptelet Pill

40 mg or 60 mg Doptelet orally 10-13 days before planned procedure.

Intervention Type DRUG

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No