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

Primary Purpose

Hemorrhage

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

HLBLS-200

About this trial

This is an interventional other trial for Hemorrhage focused on measuring Hemostatic, Blood oozing, Absorbent hemostatic, Liver resection, Intraperitoneal surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hanyang Univ. Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HLBLS-200

Arm Description

HLBLS-200, absorbent hemostactic powder, will be applied intraoperatively to stop blood oozing during hepatic resection.

Outcomes

Primary Outcome Measures

Hemostasis at the target blood oozing site

Proportion of participants achieving hemostasis within 3 minutes after HLBLS-200 application

Adverse Event

Incidence of Adverse Event after application of HLBLS-200

Secondary Outcome Measures

Hemostasis at the target blood oozing site

Proportion of participants achieving hemostasis within 5, 7, 10 minutes after HLBLS-200 application

Time to hemostasis

Time to hemostasis at the target blood oozing site after HLBLS-200 application

Proportion of participants with abnormal laboratory value

Safety evaluation

Proportion of participants with operation site bleeding after hepatectomy

Hemorrhage at the operation site

Full Information

NCT ID

NCT03957356

First Posted

May 16, 2019

Last Updated

July 20, 2020

Sponsor

HLB Cell Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03957356

Brief Title

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

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

June 19, 2019 (Actual)

Primary Completion Date

March 2, 2020 (Actual)

Study Completion Date

July 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

HLB Cell Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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: To investigate the safety of HLBLS-200 application. To explore hemostatic function of HLBLS-200 in patients receiving hepatectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemorrhage

Keywords

Hemostatic, Blood oozing, Absorbent hemostatic, Liver resection, Intraperitoneal surgery

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single Arm, Open Label, Single Center Exploratory Clinical Trial

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HLBLS-200

Arm Type

Experimental

Arm Description

HLBLS-200, absorbent hemostactic powder, will be applied intraoperatively to stop blood oozing during hepatic resection.

Intervention Type

Device

Intervention Name(s)

HLBLS-200

Intervention Description

The amount of HLBLS-200 applied will be determined by the investigator based on the resection area.

Primary Outcome Measure Information:

Title

Hemostasis at the target blood oozing site

Description

Proportion of participants achieving hemostasis within 3 minutes after HLBLS-200 application

Time Frame

within 3 minutes

Title

Adverse Event

Description

Incidence of Adverse Event after application of HLBLS-200

Time Frame

up to 12 weeks

Secondary Outcome Measure Information:

Title

Hemostasis at the target blood oozing site

Description

Proportion of participants achieving hemostasis within 5, 7, 10 minutes after HLBLS-200 application

Time Frame

within 10 minutes

Title

Time to hemostasis

Description

Time to hemostasis at the target blood oozing site after HLBLS-200 application

Time Frame

within 10 minutes

Title

Proportion of participants with abnormal laboratory value

Description

Safety evaluation

Time Frame

up to 12 weeks

Title

Proportion of participants with operation site bleeding after hepatectomy

Description

Hemorrhage at the operation site

Time Frame

up to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dongho Choi, MD, Ph.D

Organizational Affiliation

Hanyang Univ. Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hanyang Univ. Medical Center

City

Seoul

ZIP/Postal Code

04763

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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