None listed
Conditions
Sponsors
HLB CELL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At the time of screening 1) Patients over the age of 19 years with scheduled non-emergency liver resection (laparotomy or laparoscopic surgery). 2) Patients who have provided written consent to participate in this clinical trial voluntarily. During liver resection 1) Patients requiring hemostasis for exudative hemorrhage after having performed primary hemostasis (suture, ligature, vascular clip, argon beam coagulation, and electrocautery, etc.) for the hemorrhage site during liver resection.
Exclusion criteria
Exclusion criteria: At the time of screening 1) Patients with a past history of hemorrhage, platelet, and bone marrow disorder. 2) Patients with a history of liver transplant. 3) Patients with a blood coagulation disorder (PLT 2) 4) Patients with renal dysfunction (creatinine clearance rate (CrCl) < 30 mL/min) 5) Patients with hepatic dysfunction (ALT or AST is higher than 3 times the normal upper limit) 6) Patients with diseases causing potentially reduced activation of the fibrinolysis system such as disseminated intravascular coagulation (DIC), etc. 7) Patients are administered with drugs that affect hemorrhage and hemostasis, including anti-coagulants (example; Clopidogrel, Warfarin, etc.), antiplatelet drugs and thrombolytic agents, etc. within 2 weeks before the surgery. 8) Patients with allergies and/or hypersensitivity to or relevant past medical history regarding the ingredients included in the experimental device or control device (hyaluronic acid, chondroitin sulfate, e-Poly-L-lysine, polysaccharides). 9) Patients who abuse alcohol or drugs. 10) Pregnant or breast-feeding women 11) Females in childbearing age or males who are planning a pregnancy or have no intention to use any effective birth control method (condom, oral birth control pill, and installation of intrauterine contraception, injection, transplant and birth control patch, etc., or absolute abstinence, etc. are medically allowed birth control methods. Regularly scheduled abstinence (example: Calendar method, ovulation method, and symptomatic body temperature method) and self-control are not considered to be acceptable birth control methods) during the clinical trial period. 12) Patients who have been administered a medical drug or have used a medical device for another clinical trial within 4 weeks before participation in this clinical trial. 13) Other patients whom the investigator deems unsuitable to participate in this clinical trial. During liver resection 1) Patients with major hemorrhage (spurting hemorrhage; arterial hemorrhage or hemorrhage that manifests in the main vein (the hepatic vein that joins the inferior vena cava)) even after having rendered hemostasis with primary hemostatic treatment during surgery. 2) Patients determined to require administration of an anticoagulant within 48 hours of surgery. 3) Other patients whom the investigator deems unsuitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemostasis at the target blood oozing site;Safety : Advers event | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemostasis success rate in hemorrhage site within 3, 4, 7 and 10 minutes;Time to hemostasis;Proportion of participants with operation site bleeding after hepatectomy;Laboratory tests (hematological, blood chemical, blood coagulation, urine test);Vital signs;Physical examination | — |
Countries
Korea, Republic of
Contacts
Public ContactSangeun Cho
HLB CELL
Outcome results
None listed