Study of Collagen-Based Thrombin Hemostat for the Control of Bleeding in Spinal Surgery

January 15, 2026 updated by: DALIM TISSEN Co., Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
    • Gangnam-gu
      • Seoul, Gangnam-gu, South Korea, 06273
        • Gangnam Severance Hospital
    • Giheung-gu
      • Yongin-si, Giheung-gu, South Korea, 16995
        • Yongin Severance Hospital
    • Seodaemun-gu
      • Seoul, Seodaemun-gu, South Korea, 03722
        • Severance Hospital, Yonsei University Health Syetem

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. An individual who has voluntarily signed the written consent form for participating in the research as a trial subject
  2. Patients aged 20 or older
  3. Patients who are able to participate throughout the entire clinical trial period
  4. Patient scheduled to have spinal surgery due to spinal stenosis, spinal tumor, injury, etc.
  5. Patients for whom hemostasis is difficult to achieve using standard procedures
  6. 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.).

Exclusion Criteria:

  1. Pregnant women or those planning to become pregnant within 1 month after application of the collagen-based hemostat
  2. Individuals with hypersensitivity to bovine-, porcine-, or animal-derived materials
  3. Individuals deemed inappropriate for participation by the investigators
  4. Patients who are using treatments that may affect the test results
  5. Patients with active infections at the surgical site
  6. Patients with contraindications to the use of local hemostatic materials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Study Group
Group applied with CollaStat®
Device: 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
Active Comparator: Control Group
Group applied with Floseal®
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Hemostasis at the first bleeding site is confirmed at 1 minute, 2 minutes, 3 minutes, 6 minutes, and 10 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to hemostasis
Time Frame: Intraoperation
Record the time point when hemostasis is achieved.
Intraoperation
Number of hemostats used
Time Frame: Intraoperation
Record the number of hemostats used until hemostasis.
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
Length of hospital stay is defined as the number of days from the date of surgery (Visit 2) to the date of hospital discharge.
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)
Adverse events include hematoma and infection.
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
Record the drain amount until the 3rd postoperative day.
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)
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
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.
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
DALIM TISSEN Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 19, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 18, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DRT-CS01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided. The plan for sharing individual participant data has not yet been determined.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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