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

NCT06642740 | Enrolling By Invitation

• 1 other identifier: DTXY29
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Liver Disease; Thrombopenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse event rate

  2024-2025

Study Arms (2)

Platelet count: <40×10^9/L

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

Other: 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

Interventions

Platelet count OTHER

divide into two groups based on platelet count

Platelet count :40-50×10^9/L; Platelet count: <40×10^9/L

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Ditan Hospital: lead

Study Sites (1)

Beijing Ditan Hospital,Capital Medical University

Beijing, Beijing Municipality, 100015, China

Location

MeSH Terms

Conditions

Thrombocytopenia

Interventions

Platelet Count

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Platelet Function Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Yao Xie, Doctor

  Beijing Ditan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: October 13, 2024
• First Posted: October 15, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

CN (1)