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

Study on the Efficacy and Safety of Avatricopal in Patients With Chronic Liver Disease With Selective Invasive and Minimally Invasive Surgery Combined With Thrombocytopenia

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Chronic Liver Disease; Thrombopenia
• Intervention / Treatment: Other: Platelet count

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.

• Study Type: Observational
• Enrollment (Estimated): 69

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100015
      • Beijing Ditan Hospital,Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with chronic liver disease complicated with thrombocytopenia undergoing elective invasive and minimally invasive surgery were admitted to the experimental group for clinical observation.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Platelet count: <40×10^9/L; Subjects with platelet count <40×10^9/L will be given 60mg/ day of avatracopal	Other: Platelet count; 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	Other: Platelet count; divide into two groups based on platelet count

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with platelet count ≥50×10^9/L on the day of elective invasive and minimally invasive surgery.	Proportion of patients with platelet count ≥50×10^9/L on the day of elective invasive and minimally invasive surgery.	2024-2025

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event rate	Recent and long-term thrombotic events and bleeding events	2024-2025

Collaborators and Investigators

• Sponsor: Beijing Ditan Hospital
• Investigators: Principal Investigator: Yao Xie, Doctor, Beijing Ditan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: October 13, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Hematologic Diseases; Blood Platelet Disorders; Cytopenia; Liver Diseases; Thrombocytopenia
• Other Study ID Numbers: DTXY29

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No