Study on the Efficacy and Safety of Avatricopal in Patients With CLD Complicated With Thrombocytopenia

NCT ID: NCT06642740

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 69 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-06-01

Brief Summary

In this study, patients with chronic liver disease undergoing selective invasive and minimally invasive surgery combined with thrombocytopenia were enrolled. After enrollment, liver disease treatment was supplemented with avatripopal for 5 days. Biochemical indexes of avatripopal were monitored during treatment and after withdrawal. The proportion of patients with platelet count ≥50×10^9/L on the day of selective invasive and minimally invasive surgery was analyzed. The incidence of adverse events was observed.

Detailed Description

This is a single-center, single-arm, prospective study. Patients with chronic liver disease undergoing selective invasive and minimally invasive surgery combined with thrombocytopenia. After enrollment, liver disease treatment was supplemented with avatripopal for 5 days. The baseline demographic data and biochemical data of the subjects were collected. Biochemical indexes of avatripopal were monitored during treatment and after withdrawal. The proportion of patients with platelet count ≥50×10^9/L on the day of selective invasive and minimally invasive surgery was analyzed. The incidence of adverse events was observed. To investigate the efficacy and safety of avatripopal in chronic liver disease patients with thrombocytopenia undergoing elective invasive and minimally invasive surgery. To provide reference for related clinical treatment.

Conditions

Chronic Liver Disease; Thrombopenia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Platelet count: <40×10^9/L

Subjects with platelet count \<40×10\^9/L will be given 60mg/ day of avatracopal

Platelet count

Intervention Type: OTHER

divide into two groups based on platelet count

Platelet count :40-50×10^9/L

Subjects with platelet counts of 40-50×10\^9/L will be given avatracopal 40mg/ day

Platelet count

Intervention Type: OTHER

divide into two groups based on platelet count

Interventions

Platelet count

divide into two groups based on platelet count

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Voluntarily join the study and sign the informed consent;
• Age ≥18 years old, male or female;
• Baseline platelet count < 50×10^9/L;
• Patients with chronic liver disease undergoing elective invasive and minimally invasive surgery;
• No fertility requirements.

Exclusion Criteria

• History of arterial or venous thrombosis within 6 months prior to baseline;
• Plan to receive platelet transfusion or platelet-containing blood products within 7 days prior to baseline visit;
• Anticoagulant or antiplatelet therapy cannot be suspended before surgery according to the standard (low-dose aspirin is allowed to continue);
• currently receiving treatment with recombinant human thrombopoietin or thrombopoietin receptor agonists (such as rhTPO, Etopopal, or romipristine);
• The subjects had severe arteriosclerosis, cerebral thrombosis tendency, coronary artery stenosis > 70%;
• Patients with a history of arterial or venous thrombosis within 6 months before enrollment;
• Patients with known portal vein blood flow velocity < 10 cm/s or previous portal vein thrombosis within 6 months before enrollment;
• Prior to enrollment, any known primary blood history (e.g., immune thrombocytopenia, myelodysplastic syndrome, aplastic anemia);
• A known history of hereditary prethrombotic syndrome prior to admission (e.g., VLeiden mutation, prothrombin G20210A mutation, or hereditary antithrombin III (ATIII) deficiency);
• A history of major cardiovascular disease within the 6 months prior to enrollment (e.g., aggravated congestive heart failure, arrhythmias known to increase the risk of thromboembolic events [such as atrial fibrillation], coronary or peripheral arterial stenting or angioplasty, and coronary or peripheral arterial bypass grafting);
• the subject is allergic to avatripopal or any of its excipients;
• Exclude vulnerable people with mental disorders and other disabilities
• The investigator believes that accompanying medical history may affect the safe completion of the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Ditan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yao Xie

Head of Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yao Xie, Doctor

Role: PRINCIPAL_INVESTIGATOR

Beijing Ditan Hospital

Locations

Beijing Ditan Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

DTXY29

Identifier Type: -

Identifier Source: org_study_id