Spinal TumorNCT07354178
Study of Collagen-Based Thrombin Hemostat for the Control of Bleeding in Spinal Surgery
A study testing CollaStat® and Floseal® in people with Spinal Tumor and Spinal Injury, run by DALIM TISSEN Co., Ltd. at 3 sites in South Korea.
Trial summary
This clinical trial evaluates the effectiveness and safety of a collagen-based hemostatic agent containing thrombin in patients undergoing spinal surgery. The study compares this investigational product with an existing hemostatic agent to assess whether it performs equally well in controlling surgical bleeding. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Spinal Tumor, Spinal Injury, Hemostasis
- What is being tested?
- CollaStat® and Floseal®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 22 Oct 2024to 18 Aug 2025
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An individual who has voluntarily signed the written consent form for participating in the research as a trial subject
- Patients aged 20 or older
- Patients who are able to participate throughout the entire clinical trial period
- Patient scheduled to have spinal surgery due to spinal stenosis, spinal tumor, injury, etc.
- Patients for whom hemostasis is difficult to achieve using standard procedures
- Patients with grade 3 or higher bleeding * Grade 4 or 5 bleeding is reduced to grade 3 by normal procedures (compression, sutures, electrosurgical scalpel, etc.).
Who cannot join
- Pregnant women or those planning to become pregnant within 1 month after application of the collagen-based hemostat
- Individuals with hypersensitivity to bovine-, porcine-, or animal-derived materials
- Individuals deemed inappropriate for participation by the investigators
- Patients who are using treatments that may affect the test results
- Patients with active infections at the surgical site
- Patients with contraindications to the use of local hemostatic materials
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Gangnam Severance Hospital
Seoul, Gangnam-gu, 06273
Severance Hospital, Yonsei University Health Syetem
Seoul, Seodaemun-gu, 03722
Yongin Severance Hospital
Yongin-si, Giheung-gu, 16995
About this study
Official title: Randomized Clinical Trial to Assess Hemostasis by Applying Collagen-based Thrombin-containing Hemostat in Spinal Surgery
This clinical trial evaluates the effectiveness and safety of a collagen-based hemostatic agent containing thrombin in patients undergoing spinal surgery. The study compares this investigational product with an existing hemostatic agent to assess whether it performs equally well in controlling surgical bleeding. Patients with spinal stenosis, tumors, or trauma who require spinal surgery will be enrolled. The hemostat will be applied intraoperatively when grade 3 bleeding is observed. The study aims to determine how well the product works in achieving hemostasis and its safety when it is used during surgery.
Read the detailed description
This was a randomized, single-blind, active-controlled clinical trial designed to assess the non-inferiority of a collagen-based thrombin-containing topical hemostat (CollaStat) compared to an existing hemostatic agent (Floseal) in patients undergoing spinal surgery. The investigational product was designed to be highly biocompatible to reduce adverse effects in case of in-body residue after application. Patients who underwent spinal surgery due to spinal stenosis, tumors, or trauma were enrolled and randomized in a 1:1 ratio. The hemostatic products were applied intraoperatively at bleeding sites classified as grade 3. For grade 4 or 5 bleeding, temporary hemostatic procedures were performed first to reduce bleeding intensity before applying the assigned hemostat. The study's primary endpoint was the hemostasis success rate, defined as the achievement of hemostasis within 1 minute, 2 minutes, 3 minutes, 6 minutes, and 10 minutes of product application without additional intervention. Secondary outcomes included time to hemostasis, number of hemostatic units used per patient, volume of postoperative surgical drainage, length of hospital stay, incidence of intraoperative rebleeding, occurrence of postoperative hematoma or surgical site infection, and overall hemostatic effect assessed across all treated bleeding sites.
- Conditions
- Spinal Tumor, Spinal Injury, Hemostasis, Spinal Stenosis, Spinal Surgery, Intraoperative Bleeding
- Being tested
- CollaStat®, Floseal®
- Medical subject headings
- Spinal Cord Neoplasms, Spinal Injuries, Spinal Stenosis, Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CollaStat®Device
Clinical subjects are enrolled after the clinical investigator confirms that there are bleeding sites where hemostasis by normal procedures (compression, suturing, electrosurgical scalpel, etc.) is ineffective or difficult to perform. To arrest intraoperative bleeding, the study group is treated with Dalim Tissen's CollaStat® and compressed with general gauze.
Floseal®Device
Clinical subjects are enrolled after the clinical investigator confirms that there are bleeding sites where hemostasis by normal procedures (compression, suturing, electrosurgical scalpel, etc.) is ineffective or difficult to perform. To arrest intraoperative bleeding, the control group is treated with Baxter's Floseal® and compressed with general gauze
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Group applied with CollaStat® Receives: Device: Floseal® |
| Control Group | Active comparator | Group applied with Floseal® Receives: Device: CollaStat® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemostasis success rate
After applying the haemostatic agent to the bleeding site, gentle compression is performed using surgical gauze. After lifting the gauze and washing off the excess hemostatic agent, check if hemostasis is maintained
Measured: Hemostasis at the first bleeding site is confirmed at 1 minute, 2 minutes, 3 minutes, 6 minutes, and 10 minutes
Secondary outcomes (7)
Time to hemostasis
Record the time point when hemostasis is achieved.
Measured: Intraoperation
Number of hemostats used
Record the number of hemostats used until hemostasis.
Measured: Intraoperation
Length of Hospital Stay
Length of hospital stay is defined as the number of days from the date of surgery (Visit 2) to the date of hospital discharge.
Measured: From the date of surgical operation (Visit 2) until the date of hospital discharge, assessed up to 1 week (±3 days) after surgery
Incidence of adverse events
Adverse events include hematoma and infection.
Measured: From first application of the investigational medical device through end of follow-up (up to 8 weeks post-surgery)
Drain amount
Record the drain amount until the 3rd postoperative day.
Measured: 3 days after surgery
Presence of rebleeding at the index bleeding site
Measured: From first application (Visit 2; day of surgery) through end of follow-up (up to 8 weeks post-surgery)
Evaluation of Handling Characteristics (as Assessed by the Surgeon)
Hemostasis will be assessed intraoperatively at all treated bleeding sites after application of the investigational product (IP). Only the assigned IP should be used for the same patient.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start22 Oct 2024
- Primary completion19 Jun 2025
- Study completion18 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal TumorStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- DALIM TISSEN Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354178
- Sponsor's protocol ID
- DRT-CS01
- Status last verified
- Jan 2026
- First submitted
- 24 Nov 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided. The plan for sharing individual participant data has not yet been determined.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Assess Hemostasis by Applying Collagen-based Thrombin-containing Hemostat in Spinal Surgery
- ClinicalTrials.gov ID
- NCT07354178
- Acronym / sponsor ID
- DRT-CS01
- Conditions
- Spinal Tumor, Spinal Injury, Hemostasis, Spinal Stenosis, Spinal Surgery, Intraoperative Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- DALIM TISSEN Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 18 Aug 2025 (actual)
- First posted
- 21 Jan 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 clinical trial evaluates the effectiveness and safety of a collagen-based hemostatic agent containing thrombin in patients undergoing spinal surgery. The study compares this investigational product with an existing hemostatic agent to assess whether it performs equally well in controlling surgical bleeding. Patients with spinal stenosis, tumors, or trauma who require spinal surgery will be enrolled. The hemostat will be applied intraoperatively when grade 3 bleeding is observed. The study aims to determine how well the product works in achieving hemostasis and its safety when it is used during surgery.
Detailed description
This was a randomized, single-blind, active-controlled clinical trial designed to assess the non-inferiority of a collagen-based thrombin-containing topical hemostat (CollaStat) compared to an existing hemostatic agent (Floseal) in patients undergoing spinal surgery. The investigational product was designed to be highly biocompatible to reduce adverse effects in case of in-body residue after application. Patients who underwent spinal surgery due to spinal stenosis, tumors, or trauma were enrolled and randomized in a 1:1 ratio. The hemostatic products were applied intraoperatively at bleeding sites classified as grade 3. For grade 4 or 5 bleeding, temporary hemostatic procedures were performed first to reduce bleeding intensity before applying the assigned hemostat. The study's primary endpoint was the hemostasis success rate, defined as the achievement of hemostasis within 1 minute, 2 minutes, 3 minutes, 6 minutes, and 10 minutes of product application without additional intervention. Secondary outcomes included time to hemostasis, number of hemostatic units used per patient, volume of postoperative surgical drainage, length of hospital stay, incidence of intraoperative rebleeding, occurrence of postoperative hematoma or surgical site infection, and overall hemostatic effect assessed across all treated bleeding sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Device: Floseal®Group applied with CollaStat® |
| Control Group | Active comparator | Device: CollaStat®Group applied with Floseal® |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- An individual who has voluntarily signed the written consent form for participating in the research as a trial subject
- Patients aged 20 or older
- Patients who are able to participate throughout the entire clinical trial period
- Patient scheduled to have spinal surgery due to spinal stenosis, spinal tumor, injury, etc.
- Patients for whom hemostasis is difficult to achieve using standard procedures
Key exclusion criteria (6 listed)
- Pregnant women or those planning to become pregnant within 1 month after application of the collagen-based hemostat
- Individuals with hypersensitivity to bovine-, porcine-, or animal-derived materials
- Individuals deemed inappropriate for participation by the investigators
- Patients who are using treatments that may affect the test results
- Patients with active infections at the surgical site
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 |
|---|---|---|
| CollaStat®Clinical subjects are enrolled after the clinical investigator confirms that there are bleeding sites where hemostasis by normal procedures (compression, suturing, electrosurgical scalpel, etc.) is ineffective or difficult to perform. To arrest intraoperative bleeding, the study group is treated with Dalim Tissen's CollaStat® and compressed with general gauze. | Device | Control Group |
| Floseal®Clinical subjects are enrolled after the clinical investigator confirms that there are bleeding sites where hemostasis by normal procedures (compression, suturing, electrosurgical scalpel, etc.) is ineffective or difficult to perform. To arrest intraoperative bleeding, the control group is treated with Baxter's Floseal® and compressed with general gauze | Device | Study Group |
Primary outcome
Hemostasis success rate
Time frame: Hemostasis at the first bleeding site is confirmed at 1 minute, 2 minutes, 3 minutes, 6 minutes, and 10 minutes
After applying the haemostatic agent to the bleeding site, gentle compression is performed using surgical gauze. After lifting the gauze and washing off the excess hemostatic agent, check if hemostasis is maintained
7 secondary outcomes
Time to hemostasis
Time frame: Intraoperation
Number of hemostats used
Time frame: Intraoperation
Length of Hospital Stay
Time frame: From the date of surgical operation (Visit 2) until the date of hospital discharge, assessed up to 1 week (±3 days) after surgery
Incidence of adverse events
Time frame: From first application of the investigational medical device through end of follow-up (up to 8 weeks post-surgery)
Drain amount
Time frame: 3 days after surgery
Presence of rebleeding at the index bleeding site
Time frame: From first application (Visit 2; day of surgery) through end of follow-up (up to 8 weeks post-surgery)
Evaluation of Handling Characteristics (as Assessed by the Surgeon)
Time frame: Intraoperative
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 21 Jan 2026.
- Individual participant dataSharing planned: Undecided. Undecided. The plan for sharing individual participant data has not yet been determined.
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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 study testing CollaStat® and Floseal® in people with Spinal Tumor and Spinal Injury, run by DALIM TISSEN Co., Ltd. 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 6 inclusion and 6 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 21 Jan 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.
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 success rate (time frame: Hemostasis at the first bleeding site is confirmed at 1 minute, 2 minutes, 3 minutes, 6 minutes, and 10 minutes). 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 21 Jan 2026.