Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hemostasis | — | UNRESOLVED | — |
| Intraoperative Bleeding | — | UNRESOLVED | — |
| Spinal Injury | — | UNRESOLVED | — |
| Spinal Stenosis | — | UNRESOLVED | — |
| Spinal Surgery | — | UNRESOLVED | — |
| Spinal Tumor | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CollaStat® | Device | — | UNRESOLVED |
| Floseal® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Study Group
- description
- Group applied with CollaStat®
- interventionNames
- Device: Floseal®
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- Group applied with Floseal®
- interventionNames
- Device: CollaStat®
Primary outcomes (1)
- measure
- Hemostasis success rate
- timeFrame
- Hemostasis at the first bleeding site is confirmed at 1 minute, 2 minutes, 3 minutes, 6 minutes, and 10 minutes
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available