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

DALIM TISSEN Co., Ltd.

Status: Completed

Conditions: Spinal Tumor; Hemostasis; Spinal Surgery; Spinal Stenosis; Intraoperative Bleeding; Spinal Injury

Treatments: Device: CollaStat®; Device: Floseal®

Study type: Interventional

Funder types: Industry

Identifiers

NCT07354178

DRT-CS01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups

Study Group

Experimental group

Description:

Group applied with CollaStat®

Treatment:

Device: Floseal®

Control Group

Active Comparator group

Description:

Group applied with Floseal®

Treatment:

Device: CollaStat®