Surgical HemorrhagePhase 3NCT07824024
A Phase III Study of Hemofence for Hemostasis in Patients With Uncontrolled Exudative Hemorrhage During Spinal Or Orthopedic Surgery
A Phase 3 study testing Hemofence and Floseal hemostatic matrix in people with Surgical Hemorrhage, run by BMI Korea at 3 sites in South Korea.
Trial summary
This Phase 3 study was conducted to evaluated the efficacy and safety of Hemofence compared with Floseal Hemostatic Matrix in patients undergoing spinal or orthopedic surgery who required hemostasis for exudative bleeding that could not be adequately controlled by conventional procedures. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Surgical Hemorrhage
- What is being tested?
- Hemofence and Floseal hemostatic matrix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 3 Dec 2020to 19 Apr 2022
- Phase
- Phase 3
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- [At Screening (Preoperative)]
- Individuals aged 19 years or older and under 80 years, scheduled for non-emergency spinal/orthopedic surgery
- Subjects who have voluntarily agreed to participate after receiving a thorough explanation of the clinical trial and fully understanding its details, and who have provided written informed consent to comply with the instructions of the trial
- [Surgery Day (Preoperative)]
- Subjects with an INR result of ≤ 1.5 in tests performed before surgery
- Subjects with normal platelet function or results below the lower limit of normal in platelet adhesion COL/EPI tests, but deemed clinically insignificant by the investigator
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- [Surgery Day (Intraoperative)]
- Subjects requiring hemostasis for exudative hemorrhage that cannot be effectively controlled or is uncontrollable by conventional procedures
- Subjects without severe arterial bleeding or similar conditions
Who cannot join
- Subjects who received platelet or plasma transfusions affecting hemostasis within 3 weeks prior to the surgery day
- Subjects with active infections at the surgical site
- Subjects with a history of bleeding, platelet, or bone marrow disorders
- Subjects with coagulation disorders
- Subjects with immune system diseases
- Subjects currently receiving or scheduled to receive procoagulants, antifibrinolytics, or aprotinin during surgery
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- Subjects scheduled to use antibiotic solutions or powders at the investigational product application site during surgery (excluding irrigation agents applied after the hemostasis evaluation at the investigational product application site and during surgical site closure)
- Subjects who received medication affecting bleeding and hemostasis (e.g., anticoagulants, antiplatelet agents, thrombolytics such as aspirin, clopidogrel, NSAIDs, warfarin) within 7 days prior to the surgery date (Visit 2)
- Subjects who expected to require anticoagulatnt therapy within 48 hours postoperatively
- Subjects with hypersensitivity to bovine-derived materials or any component of the investigational product
- Subjects with renal implairment (serum creatinine levels exceeding 1.5 times the institution's upper limit of normal)
- Subjects with hepatic impairment (ALT or AST levels exceeding 3.0 times the institution's upper limit of normal)
- Subjects with disease such as disseminated intravascular coagulation (DIC) or other conditions of concern regarding decreased fibrinolytic system activity
- Subject with a history of alcohol or drug abuse
- Female subjects with childbearing potential or male subjects with partners of childbearing potential who are unwilling to use medically accepted contraception methods during the clinical trial period (e.g., hormonal contraception, intrauterine device [IUD] or intrauterine system [IUS], tubal ligation, double barrier methods such as male or female condoms, cervical caps, diaphragms, or sponges combined with spermicide, or a single barrier method with spermicide)
- Pregnant or breastfeeding women
- Subjects who participated in another clinical trial within 4 weeks prior to this trial
- Any other condition that the investigator deems unsuitable for participation
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Hanllym University Dongtan St.Heart Hospital
Hwaseong-si
Korea University Anam Hospital
Seoul
Korea University Guro Hospital
Seoul
About this study
Official title: A Multicenter, Randomized, Single-blind, Active-Controlled, Parallel Group, Phase III Clinical Study Report to Evaluate the Efficacy and Safety of 'Hemofence' for Hemostasis in Patients With Exudative Hemorrhage Uncontrolled or Ineffectively Controlled by Conventional Procedures in Spinal/Orthopedic Surgery
This Phase 3 study was conducted to evaluated the efficacy and safety of Hemofence compared with Floseal Hemostatic Matrix in patients undergoing spinal or orthopedic surgery who required hemostasis for exudative bleeding that could not be adequately controlled by conventional procedures. Eligible participants were randomly assigned in a 1:1 ratio to receive either Hemofence or Floseal Hemostatic Matrix. The primary objective was to demonstrate the non-inferiority of Hemofence to Floseal Hemostatic Matrix based on the proportion of participants who achieved successful hemostasis within 10 minutes after the initial application of the assigned treatment at the first bleeding site. Safety was assessed through adverse events, clinical laboratory tests, vital signs, electrocardiograms, and physical examinations.
- Conditions
- Surgical Hemorrhage
- Being tested
- Hemofence, Floseal hemostatic matrix
- Keywords
- Exudative hemorrhage, Oozing bleeding, Surgical hemostasis, Spinal surgery, Orthopedic surgery, Hemofence, Floseal Hemostatic Matrix
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemofenceDrug
Hemofence was applied during spinal or orthopedic surgery to exudative bleeding that could not be adequately controlled conventional procedures. One kit was applied per 3X3cm² bleeding area. The treatment was applied to the first and, if present, second eligible bleeding sites. If bleeding persisted, one additional application was permitted at each site. Hemostasis was assessed within 10 minutes after the initial application.
Floseal hemostatic matrixDrug
Floseal Hemostatic Metrix was applied during spinal or orthopedic surgery to exudative bleeding that could not be adequately controlled conventional procedures. One kit was applied per 3X3cm² bleeding area. The treatment was applied to the first and, if present, second eligible bleeding sites. If bleeding persisted, one additional application was permitted at each site. Hemostasis was assessed within 10 minutes after the initial application.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants assigned to this arm received Hemofence for exudative bleeding that could not adequately controlled by conventional procedures during spinal or orthopedic surgery. Receives: Drug: Hemofence |
| Active Control Group | Active comparator | Participants assigned to this arm received Floseal Hemostatic Matrix for exudative bleeding that could not adequately controlled by conventional procedures during spinal or orthopedic surgery. Receives: Drug: Floseal hemostatic matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Successful Hemostasis at the First Bleeding Site Within 10 Minutes
Measured: Within 10 minutes after the initial application of the assigned treatment
Secondary outcomes (3)
Percentage of Participants With Successful Hemostasis at the Second Bleeding Site
Measured: Within 10 minutes after the initial or subsequent application of the assigned treatment
Time to Hemostasis at the First Bleeding Site
Measured: From application of the assigned treatment until hemostasis, up to 10 minutes
Time to Hemostasis at the Second Bleeding Site
Measured: From application of the assigned treatment until hemostasis, up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start3 Dec 2020
- Primary completion24 Mar 2022
- Study completion19 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- BMI Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824024
- Sponsor's protocol ID
- BMI1001-SIT-01
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Single-blind, Active-Controlled, Parallel Group, Phase III Clinical Study Report to Evaluate the Efficacy and Safety of 'Hemofence' for Hemostasis in Patients With Exudative Hemorrhage Uncontrolled or Ineffectively Controlled by Conventional Procedures in Spinal/Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT07824024
- Acronym / sponsor ID
- BMI1001-SIT-01
- Conditions
- Surgical Hemorrhage
- Keywords
- Exudative hemorrhage, Oozing bleeding, Surgical hemostasis, Spinal surgery, Orthopedic surgery, Hemofence, Floseal Hemostatic Matrix
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- BMI KoreaIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 17 Sep 2026 (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 Phase 3 study was conducted to evaluated the efficacy and safety of Hemofence compared with Floseal Hemostatic Matrix in patients undergoing spinal or orthopedic surgery who required hemostasis for exudative bleeding that could not be adequately controlled by conventional procedures. Eligible participants were randomly assigned in a 1:1 ratio to receive either Hemofence or Floseal Hemostatic Matrix. The primary objective was to demonstrate the non-inferiority of Hemofence to Floseal Hemostatic Matrix based on the proportion of participants who achieved successful hemostasis within 10 minutes after the initial application of the assigned treatment at the first bleeding site. Safety was assessed through adverse events, clinical laboratory tests, vital signs, electrocardiograms, and physical examinations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: HemofenceParticipants assigned to this arm received Hemofence for exudative bleeding that could not adequately controlled by conventional procedures during spinal or orthopedic surgery. |
| Active Control Group | Active comparator | Drug: Floseal hemostatic matrixParticipants assigned to this arm received Floseal Hemostatic Matrix for exudative bleeding that could not adequately controlled by conventional procedures during spinal or orthopedic surgery. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- [At Screening (Preoperative)]
- Individuals aged 19 years or older and under 80 years, scheduled for non-emergency spinal/orthopedic surgery
- Subjects who have voluntarily agreed to participate after receiving a thorough explanation of the clinical trial and fully understanding its details, and who have provided written informed consent to comply with the instructions of the trial
- [Surgery Day (Preoperative)]
- Subjects with an INR result of ≤ 1.5 in tests performed before surgery
Key exclusion criteria (18 listed)
- Subjects who received platelet or plasma transfusions affecting hemostasis within 3 weeks prior to the surgery day
- Subjects with active infections at the surgical site
- Subjects with a history of bleeding, platelet, or bone marrow disorders
- Subjects with coagulation disorders
- Subjects with immune system diseases
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 |
|---|---|---|
| HemofenceHemofence was applied during spinal or orthopedic surgery to exudative bleeding that could not be adequately controlled conventional procedures. One kit was applied per 3X3cm² bleeding area. The treatment was applied to the first and, if present, second eligible bleeding sites. If bleeding persisted, one additional application was permitted at each site. Hemostasis was assessed within 10 minutes after the initial application. | Drug | Experimental Group |
| Floseal hemostatic matrixFloseal Hemostatic Metrix was applied during spinal or orthopedic surgery to exudative bleeding that could not be adequately controlled conventional procedures. One kit was applied per 3X3cm² bleeding area. The treatment was applied to the first and, if present, second eligible bleeding sites. If bleeding persisted, one additional application was permitted at each site. Hemostasis was assessed within 10 minutes after the initial application. | Drug | Active Control Group |
Primary outcome
Percentage of Participants With Successful Hemostasis at the First Bleeding Site Within 10 Minutes
Time frame: Within 10 minutes after the initial application of the assigned treatment
3 secondary outcomes
Percentage of Participants With Successful Hemostasis at the Second Bleeding Site
Time frame: Within 10 minutes after the initial or subsequent application of the assigned treatment
Time to Hemostasis at the First Bleeding Site
Time frame: From application of the assigned treatment until hemostasis, up to 10 minutes
Time to Hemostasis at the Second Bleeding Site
Time frame: From application of the assigned treatment until hemostasis, up to 10 minutes
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 17 Sep 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hemofence and Floseal hemostatic matrix in people with Surgical Hemorrhage, run by BMI Korea at 3 sites 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 9 inclusion and 18 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 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percentage of Participants With Successful Hemostasis at the First Bleeding Site Within 10 Minutes (time frame: Within 10 minutes after the initial application of the assigned treatment). 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 17 Sep 2026.