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

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: Completed
• Conditions: Spinal Stenosis; Hemostasis; Spinal Tumor; Spinal Surgery; Intraoperative Bleeding; Spinal Injury
• Intervention / Treatment: Device: Floseal®; Device: CollaStat®

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: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	Hemostasis at the first bleeding site is confirmed at 1 minute, 2 minutes, 3 minutes, 6 minutes, and 10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to hemostasis	Record the time point when hemostasis is achieved.	Intraoperation
Number of hemostats used	Record the number of hemostats used until hemostasis.	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.	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.	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.	3 days after surgery
Presence of rebleeding at the index bleeding site		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.	Intraoperative

Collaborators and Investigators

• Sponsor: DALIM TISSEN Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2024
• Primary Completion (Actual): June 19, 2025
• Study Completion (Actual): August 18, 2025

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Neoplasms by Site; Neoplasms; Hemorrhage; Spinal Diseases; Nervous System Neoplasms; Central Nervous System Neoplasms; Spinal Cord Diseases; Intraoperative Complications; Back Injuries; Pathological Conditions, Signs and Symptoms; Spinal Stenosis; Spinal Cord Neoplasms; Blood Loss, Surgical; Spinal Injuries
• Other Study ID 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