Clinical trial NCT03957356: Study to Evaluate the Safety and Efficacy of HLBLS-200 in Patients Requiring Hemostatic Technique
Official title: Single Center, Single Arm, Open-label, Exploratory Clinical Trial to Evaluate the Safety and Efficacy of HLBLS-200 in Patients Requiring Hemostatic Technique for Oozing Hemorrhage During Liver Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhage
Keywords: Hemostatic
Blood oozing
Absorbent hemostatic
Liver resection
Intraperitoneal surgery
Lead sponsor: HLB Cell Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-05-21
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Arm, Open Label, Single Center Exploratory Clinical Trial
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Exclusion Criteria: (during hepatectomy)

* Subject with following major bleeding (e.g. spurting hemorrhage, hemorrhage from hepatic veins) despite application of primary hemostatic methods
* Subject who is deemed to need anticoagulant treatment within 48 hours of hepatectomy.
* For other reason, subject who were judged by the investigator as inadequate for participation in the study.

Primary outcomes:
measure: Hemostasis at the target blood oozing site
timeFrame: within 3 minutes
measure: Adverse Event
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Hemostasis at the target blood oozing site
timeFrame: within 10 minutes
measure: Time to hemostasis
timeFrame: within 10 minutes
measure: Proportion of participants with abnormal laboratory value
timeFrame: up to 12 weeks
measure: Proportion of participants with operation site bleeding after hepatectomy
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang Univ. Medical Center
Study officials:
affiliation: Hanyang Univ. Medical Center
name: Dongho Choi, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: