None listed
Conditions
Sponsors
HLB CELL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: during screening period(pre hepatectomy) 1)Subject aged between 18 and 79 years old and scheduled for non-emergent hepatic resection. 2)Subject is willing to provide written consent and able to comply with study procedures. 3)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. during hepatectomy 1)Subjects who need to receive additional hemostatic treatment for blood oozing at the resection site after application of primary hemostatic methods.
Exclusion criteria
Exclusion criteria: during screening period(pre hepatectomy) 1)Subject with a history of bleeding disorder, platelet disorder or bone marrow disorder. 2)Platelet count < 50 X 10^9/L or International normalized ratio > 2. 3)Subject who received any drug affecting hemorrhage and/or hemostasis such as anticoagulants, antiplatelet agents or thrombolytic agent within 2 weeks prior to hepatectomy. 4)Subject with a history of hypersensitivity to the substance of the investigational device. 5)Creatinine clearance < 30mL/min 6)Aspartate transaminase or alanine aminotransferase = 3.0 X upper limit of normal. 7)Subject with a suspected disorder of decrease in fibrinolytic activity such as disseminated intravascular coagulation. 8)Subject with a history of alcohol or drug abuse. 9)Pregnant or lactating women 10)Subject who have participated in other clinical trial and have received investigation drugs or devices within 4 weeks prior to participation in the study. 11)Subject who were judged by the investigator as inadequate for participation in the study. during hepatectomy 1)Subject with following major bleeding (e.g. spurting hemorrhage, hemorrhage from hepatic veins) despite application of primary hemostatic methods 2)Subject who is deemed to need anticoagulant treatment within 48 hours of hepatectomy. 3)For other reason, subject who were judged by the investigator as inadequate for participation in the study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Safety : laboratory value;Proportion of participants achieving hemostasis within 5, 7, 10 minutes after HLBLS-200 application;Time to hemostasis;Proportion of participants with operation site bleeding after hepatectomy | — |
Primary
| Measure | Time frame |
|---|---|
| Hemostasis at the target blood oozing site;Safety : Advers event | — |
Countries
Korea, Republic of
Contacts
Public ContactChoi Ho
Hanyang University Seoul Hospital
Outcome results
None listed