Clinical trial NCT06642740: Study on the Efficacy and Safety of Avatricopal in Patients With CLD Complicated With Thrombocytopenia
Official title: Study on the Efficacy and Safety of Avatricopal in Patients With Chronic Liver Disease With Selective Invasive and Minimally Invasive Surgery Combined With Thrombocytopenia
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Chronic Liver Disease
Thrombopenia
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Proportion of patients with platelet count ≥50×10^9/L on the day of elective invasive and minimally invasive surgery.
timeFrame: 2024-2025
Secondary outcomes:
measure: Adverse event rate
timeFrame: 2024-2025
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital,Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Ditan Hospital
name: Yao Xie, Doctor
role: PRINCIPAL_INVESTIGATOR
References: