Study to Evaluate the Safety and Efficacy of HLBLS-200 in Patients Requiring Hemostatic Technique

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

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhage
• Intervention / Treatment: Device: HLBLS-200

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 04763
    • Hanyang Univ. Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HLBLS-200; HLBLS-200, absorbent hemostactic powder, will be applied intraoperatively to stop blood oozing during hepatic resection.	Device: HLBLS-200; The amount of HLBLS-200 applied will be determined by the investigator based on the resection area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemostasis at the target blood oozing site	Proportion of participants achieving hemostasis within 3 minutes after HLBLS-200 application	within 3 minutes
Adverse Event	Incidence of Adverse Event after application of HLBLS-200	up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemostasis at the target blood oozing site	Proportion of participants achieving hemostasis within 5, 7, 10 minutes after HLBLS-200 application	within 10 minutes
Time to hemostasis	Time to hemostasis at the target blood oozing site after HLBLS-200 application	within 10 minutes
Proportion of participants with abnormal laboratory value	Safety evaluation	up to 12 weeks
Proportion of participants with operation site bleeding after hepatectomy	Hemorrhage at the operation site	up to 12 weeks

Collaborators and Investigators

• Sponsor: HLB Cell Co., Ltd.
• Investigators: Principal Investigator: Dongho Choi, MD, Ph.D, Hanyang Univ. Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2019
• Primary Completion (Actual): March 2, 2020
• Study Completion (Actual): July 8, 2020

Study Registration Dates

• First Submitted: May 16, 2019
• First Submitted That Met QC Criteria: May 20, 2019
• First Posted (Actual): May 21, 2019

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Liver resection; Hemostatic; Blood oozing; Absorbent hemostatic; Intraperitoneal surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: LL-MD-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No