This is a prospective, open-label, exploratory clinical trial designed to investigate the safety and efficacy of HLBLS-200 (an investigational hemostatic agent). The study will recruit approximately 8 subjects.
Patients scheduled for hepatic resection who voluntarily agree to participate the study will be recruited for the screening procedures. Patients who meet the eligibility criteria will be assigned to the study. Subjects will receive HLBLS-200 as a supplementary hemostatic technique for oozing hemorrhage which can be occurred during hepatic resection. A dose of HLBLS-200 based on the area of liver resection will be applied and time to hemostasis of blood oozing will be evaluated. Patients will be followed for 12 weeks after application of HLBLS-200 to monitor any adverse event. Study objective: 1. To investigate the safety of HLBLS-200 application. 2. To explore hemostatic function of HLBLS-200 in patients receiving hepatectomy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
8
The amount of HLBLS-200 applied will be determined by the investigator based on the resection area.
Hanyang Univ. Medical Center
Seoul, South Korea
Hemostasis at the target blood oozing site
Proportion of participants achieving hemostasis within 3 minutes after HLBLS-200 application
Time frame: within 3 minutes
Adverse Event
Incidence of Adverse Event after application of HLBLS-200
Time frame: up to 12 weeks
Hemostasis at the target blood oozing site
Proportion of participants achieving hemostasis within 5, 7, 10 minutes after HLBLS-200 application
Time frame: within 10 minutes
Time to hemostasis
Time to hemostasis at the target blood oozing site after HLBLS-200 application
Time frame: within 10 minutes
Proportion of participants with abnormal laboratory value
Safety evaluation
Time frame: up to 12 weeks
Proportion of participants with operation site bleeding after hepatectomy
Hemorrhage at the operation site
Time frame: up to 12 weeks
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