Hemorrhage
Conditions
Keywords
Hemostatic, Blood oozing, Absorbent hemostatic, Liver resection, Intraperitoneal surgery
Brief summary
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.
Detailed description
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.
Interventions
DEVICEHLBLS-200
The amount of HLBLS-200 applied will be determined by the investigator based on the resection area.
Sponsors
HLB Cell Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single Arm, Open Label, Single Center Exploratory Clinical Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
(during screening period) * Subject aged between 18 and 80 years old and scheduled for non-emergent hepatic resection. * Subject is willing to provide written consent and able to comply with study procedures. * Female subject of childbearing potential who is willing to use an adequate method of contraception or to be abstinent during the course of the study. Inclusion Criteria: (during hepatectomy) * Subjects who need to receive additional hemostatic treatment for blood oozing at the resection site after application of primary hemostatic methods.
Exclusion criteria
(during screening period) * Subject with a history of bleeding disorder, platelet disorder or bone marrow disorder. * Platelet count \< 50 X 10\^9/L or International normalized ratio \> 2. * Subject who received any drug affecting hemorrhage and/or hemostasis such as anticoagulants, antiplatelet agents or thrombolytic agent within 2 weeks prior to hepatectomy. * Subject with a history of hypersensitivity to the substance of the investigational device. * Creatinine clearance \< 30mL/min * Aspartate transaminase or alanine aminotransferase ≥ 3.0 X upper limit of normal. * Subject with a suspected disorder of decrease in fibrinolytic activity such as disseminated intravascular coagulation. * Subject with a history of alcohol or drug abuse. * Pregnant or lactating women * Subject who have participated in other clinical trial and have received investigation drugs or devices within 4 weeks prior to participation in the study. * Subject who were judged by the investigator as inadequate for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemostasis at the target blood oozing site | within 3 minutes | Proportion of participants achieving hemostasis within 3 minutes after HLBLS-200 application |
| Adverse Event | up to 12 weeks | Incidence of Adverse Event after application of HLBLS-200 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemostasis at the target blood oozing site | within 10 minutes | Proportion of participants achieving hemostasis within 5, 7, 10 minutes after HLBLS-200 application |
| Time to hemostasis | within 10 minutes | Time to hemostasis at the target blood oozing site after HLBLS-200 application |
| Proportion of participants with abnormal laboratory value | up to 12 weeks | Safety evaluation |
| Proportion of participants with operation site bleeding after hepatectomy | up to 12 weeks | Hemorrhage at the operation site |
Countries
South Korea
Outcome results
None listed