HemorrhageNCT03957356
Study to Evaluate the Safety and Efficacy of HLBLS-200 in Patients Requiring Hemostatic Technique
A study testing HLBLS-200 in people with Hemorrhage, run by HLB Cell Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemorrhage
- What is being tested?
- HLBLS-200
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Jun 2019to 8 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Subjects who need to receive additional hemostatic treatment for blood oozing at the resection site after application of primary hemostatic methods.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Hemorrhage
- Being tested
- HLBLS-200
- Keywords
- Hemostatic, Blood oozing, Absorbent hemostatic, Liver resection, Intraperitoneal surgery
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLBLS-200Device
The amount of HLBLS-200 applied will be determined by the investigator based on the resection area.
| Study group | Role | What they receive |
|---|---|---|
| HLBLS-200 | Experimental | HLBLS-200, absorbent hemostactic powder, will be applied intraoperatively to stop blood oozing during hepatic resection. Receives: Device: HLBLS-200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemostasis at the target blood oozing site
Proportion of participants achieving hemostasis within 3 minutes after HLBLS-200 application
Measured: within 3 minutes
Adverse Event
Incidence of Adverse Event after application of HLBLS-200
Measured: up to 12 weeks
Secondary outcomes (4)
Hemostasis at the target blood oozing site
Proportion of participants achieving hemostasis within 5, 7, 10 minutes after HLBLS-200 application
Measured: within 10 minutes
Time to hemostasis
Time to hemostasis at the target blood oozing site after HLBLS-200 application
Measured: within 10 minutes
Proportion of participants with abnormal laboratory value
Safety evaluation
Measured: up to 12 weeks
Proportion of participants with operation site bleeding after hepatectomy
Hemorrhage at the operation site
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start19 Jun 2019
- Primary completion2 Mar 2020
- Study completion8 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Arm, Open Label, Single Center Exploratory Clinical Trial
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- HLB Cell Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dongho Choi, MD, Ph.D, Principal investigator, Hanyang Univ. Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957356
- Sponsor's protocol ID
- LL-MD-01
- Status last verified
- Jul 2020
- First submitted
- 16 May 2019
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03957356
- Acronym / sponsor ID
- LL-MD-01
- Conditions
- Hemorrhage
- Keywords
- Hemostatic, Blood oozing, Absorbent hemostatic, Liver resection, Intraperitoneal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- HLB Cell Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 8 Jul 2020 (actual)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Arm, Open Label, Single Center Exploratory Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| HLBLS-200 | Experimental | Device: HLBLS-200HLBLS-200, absorbent hemostactic powder, will be applied intraoperatively to stop blood oozing during hepatic resection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- Subjects who need to receive additional hemostatic treatment for blood oozing at the resection site after application of primary hemostatic methods.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLBLS-200The amount of HLBLS-200 applied will be determined by the investigator based on the resection area. | Device | HLBLS-200 |
Primary outcome
Hemostasis at the target blood oozing site
Time frame: within 3 minutes
Proportion of participants achieving hemostasis within 3 minutes after HLBLS-200 application
Adverse Event
Time frame: up to 12 weeks
Incidence of Adverse Event after application of HLBLS-200
4 secondary outcomes
Hemostasis at the target blood oozing site
Time frame: within 10 minutes
Time to hemostasis
Time frame: within 10 minutes
Proportion of participants with abnormal laboratory value
Time frame: up to 12 weeks
Proportion of participants with operation site bleeding after hepatectomy
Time frame: up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dongho Choi, MD, Ph.D principal investigator
Hanyang Univ. Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HLBLS-200 in people with Hemorrhage, run by HLB Cell Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemostasis at the target blood oozing site (time frame: within 3 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.